{"id":"https://openalex.org/W7224076908","doi":"https://doi.org/10.6084/m9.figshare.34831218","title":"Post-approval modification of high-risk chronic pain devices approved through the FDA premarket approval pathway, 1981-2023","display_name":"Post-approval modification of high-risk chronic pain devices approved through the FDA premarket approval pathway, 1981-2023","publication_year":2026,"publication_date":"2026-10-28","ids":{"openalex":"https://openalex.org/W7224076908","doi":"https://doi.org/10.6084/m9.figshare.34831218"},"language":"en","primary_location":{"id":"doi:10.6084/m9.figshare.34831218","doi":"https://doi.org/10.6084/m9.figshare.34831218","is_oa":true,"landing_page_url":"https://doi.org/10.6084/m9.figshare.34831218","pdf_url":null,"source":{"id":"https://openalex.org/S4377196282","display_name":"Figshare","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210132348","host_organization_name":"Figshare (United Kingdom)","host_organization_lineage":["https://openalex.org/I4210132348"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"},"volume":null,"type":"article","indexed_in":["datacite"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://doi.org/10.6084/m9.figshare.34831218","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5076227536","display_name":"Bassel Almarie","orcid":"https://orcid.org/0000-0002-5409-9806","observed_orcids":["https://orcid.org/0000-0002-5409-9806"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Bassel Almarie","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5023530519","display_name":"Ygor Nascimento Junqueira","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Ygor Nascimento Junqueira","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5092376953","display_name":"Mustafa Reha Dodurgali","orcid":"https://orcid.org/0009-0000-6468-8009","observed_orcids":["https://orcid.org/0009-0000-6468-8009"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Mustafa Reha Dodurgali","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"last","author":{"id":"https://openalex.org/A5062615661","display_name":"Felipe Fregni","orcid":"https://orcid.org/0000-0002-1703-7526","observed_orcids":["https://orcid.org/0000-0002-1703-7526","https://orcid.org/0000-0003-1307-9355","https://orcid.org/0000-0001-9359-8643"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Felipe Fregni","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.87664875,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.9707000255584717,"subfield":{"id":"https://openalex.org/subfields/3605","display_name":"Health Information Management"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.9707000255584717,"subfield":{"id":"https://openalex.org/subfields/3605","display_name":"Health Information Management"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11840","display_name":"Pain Management and Treatment","score":0.019999999552965164,"subfield":{"id":"https://openalex.org/subfields/2703","display_name":"Anesthesiology and Pain Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10512","display_name":"Orthopaedic implants and arthroplasty","score":0.0017999999690800905,"subfield":{"id":"https://openalex.org/subfields/2746","display_name":"Surgery"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/premarket-approval","display_name":"premarket approval","score":0.6510000228881836},{"id":"https://openalex.org/keywords/spinal-cord-stimulator","display_name":"spinal cord stimulator","score":0.8119999766349792},{"id":"https://openalex.org/keywords/shock-wave-therapy","display_name":"shock wave therapy","score":0.6679999828338623},{"id":"https://openalex.org/keywords/medical-device-recall","display_name":"medical device recall","score":0.8450000286102295},{"id":"https://openalex.org/keywords/biomedical-implants","display_name":"biomedical implants","score":0.6470000147819519},{"id":"https://openalex.org/keywords/fda-regulatory-pathways","display_name":"FDA regulatory pathways","score":0.47600001096725464}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9035999774932861},{"id":"https://openalex.org/C2778753352","wikidata":"https://www.wikidata.org/wiki/Q1668448","display_name":"Spinal cord stimulator","level":4,"score":0.6559000015258789},{"id":"https://openalex.org/C2781118164","wikidata":"https://www.wikidata.org/wiki/Q1088113","display_name":"Chronic pain","level":2,"score":0.6513000130653381},{"id":"https://openalex.org/C2779343474","wikidata":"https://www.wikidata.org/wiki/Q3109175","display_name":"Context (archaeology)","level":2,"score":0.6014999747276306},{"id":"https://openalex.org/C2779913896","wikidata":"https://www.wikidata.org/wiki/Q7063001","display_name":"Notice","level":2,"score":0.5710999965667725},{"id":"https://openalex.org/C3020535179","wikidata":"https://www.wikidata.org/wiki/Q6554101","display_name":"Medical device","level":2,"score":0.5041000247001648},{"id":"https://openalex.org/C2780775167","wikidata":"https://www.wikidata.org/wiki/Q9606","display_name":"Spinal cord","level":2,"score":0.45509999990463257},{"id":"https://openalex.org/C2984781990","wikidata":"https://www.wikidata.org/wiki/Q1668448","display_name":"Spinal cord stimulation","level":3,"score":0.38190001249313354},{"id":"https://openalex.org/C2987552334","wikidata":"https://www.wikidata.org/wiki/Q383126","display_name":"Chronic disease","level":2,"score":0.33230000734329224},{"id":"https://openalex.org/C42219234","wikidata":"https://www.wikidata.org/wiki/Q131130","display_name":"Anesthesia","level":1,"score":0.31119999289512634},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.2840000092983246},{"id":"https://openalex.org/C195910791","wikidata":"https://www.wikidata.org/wiki/Q1324077","display_name":"Medical record","level":2,"score":0.2838999927043915},{"id":"https://openalex.org/C2778375690","wikidata":"https://www.wikidata.org/wiki/Q7814214","display_name":"Tolerability","level":3,"score":0.2768000066280365},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.2727000117301941},{"id":"https://openalex.org/C1862650","wikidata":"https://www.wikidata.org/wiki/Q186005","display_name":"Physical therapy","level":1,"score":0.266400009393692},{"id":"https://openalex.org/C2779231881","wikidata":"https://www.wikidata.org/wiki/Q5977147","display_name":"Medical literature","level":2,"score":0.2646999955177307},{"id":"https://openalex.org/C2778334475","wikidata":"https://www.wikidata.org/wiki/Q1415275","display_name":"Spinal cord injury","level":3,"score":0.26269999146461487},{"id":"https://openalex.org/C502991105","wikidata":"https://www.wikidata.org/wiki/Q5133849","display_name":"Clinical research","level":2,"score":0.26109999418258667},{"id":"https://openalex.org/C177713679","wikidata":"https://www.wikidata.org/wiki/Q679690","display_name":"Intensive care medicine","level":1,"score":0.25920000672340393}],"mesh":[],"locations_count":3,"locations":[{"id":"doi:10.6084/m9.figshare.34831218","doi":"https://doi.org/10.6084/m9.figshare.34831218","is_oa":true,"landing_page_url":"https://doi.org/10.6084/m9.figshare.34831218","pdf_url":null,"source":{"id":"https://openalex.org/S4377196282","display_name":"Figshare","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210132348","host_organization_name":"Figshare (United Kingdom)","host_organization_lineage":["https://openalex.org/I4210132348"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"},{"id":"doi:10.6084/m9.figshare.34831218.v1","doi":"https://doi.org/10.6084/m9.figshare.34831218.v1","is_oa":true,"landing_page_url":"https://doi.org/10.6084/m9.figshare.34831218.v1","pdf_url":null,"source":{"id":"https://openalex.org/S4377196282","display_name":"Figshare","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210132348","host_organization_name":"Figshare (United Kingdom)","host_organization_lineage":["https://openalex.org/I4210132348"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"},{"id":"doi:10.6084/m9.figshare.34831218.v2","doi":"https://doi.org/10.6084/m9.figshare.34831218.v2","is_oa":true,"landing_page_url":"https://doi.org/10.6084/m9.figshare.34831218.v2","pdf_url":null,"source":{"id":"https://openalex.org/S4377196282","display_name":"Figshare","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210132348","host_organization_name":"Figshare (United Kingdom)","host_organization_lineage":["https://openalex.org/I4210132348"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"}],"best_oa_location":{"id":"doi:10.6084/m9.figshare.34831218","doi":"https://doi.org/10.6084/m9.figshare.34831218","is_oa":true,"landing_page_url":"https://doi.org/10.6084/m9.figshare.34831218","pdf_url":null,"source":{"id":"https://openalex.org/S4377196282","display_name":"Figshare","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210132348","host_organization_name":"Figshare (United Kingdom)","host_organization_lineage":["https://openalex.org/I4210132348"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"},"sustainable_development_goals":[{"score":0.9763000011444092,"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W1488507118","https://openalex.org/W4365136018","https://openalex.org/W3006747575","https://openalex.org/W2247570129","https://openalex.org/W2174920330","https://openalex.org/W2062443568","https://openalex.org/W4365135884","https://openalex.org/W7100182290","https://openalex.org/W2612512718","https://openalex.org/W2788738709"],"abstract_inverted_index":{"High-risk":[0],"chronic":[1,26,152],"pain":[2,27,153],"devices":[3,28,65,154,184],"undergo":[4],"postapproval":[5,191],"modifications":[6],"via":[7,169],"supplement":[8,31],"pathways":[9,115,170],"with":[10],"varying":[11],"evidentiary":[12],"requirements,":[13],"but":[14],"their":[15,189],"extent":[16],"has":[17],"not":[18,171],"been":[19],"systematically":[20],"characterized.":[21],"Cross-sectional":[22],"analysis":[23],"of":[24,74,91,124,150,161,181,188],"PMA-approved":[25],"(1981\u20132023)":[29],"using":[30],"data":[32,37],"from":[33,38],"openFDA":[34],"and":[35,105,166],"recall":[36],"the":[39,95,179,186],"FDA":[40],"Medical":[41],"Device":[42],"Recalls":[43],"database":[44],"(2005\u20132025).":[45],"Seventeen":[46],"original":[47],"PMAs":[48],"were":[49,62,102,143],"identified:":[50],"8":[51],"spinal":[52,85,139,163],"cord":[53,86,140,164],"stimulators":[54,87,165],"(47.1%),":[55],"7":[56],"shock-wave":[57],"generators":[58],"(41.2%);":[59],"10":[60],"(58.8%)":[61],"implantable.":[63],"Fourteen":[64],"(82.4%)":[66],"generated":[67],"1,343":[68],"supplements":[69],"over":[70],"a":[71,158],"median":[72,99],"follow-up":[73],"4.5":[75],"years":[76],"(IQR,":[77],"2.8\u201320.7).":[78],"Supplement":[79],"activity":[80],"was":[81,155],"highly":[82],"concentrated:":[83],"3":[84],"accounted":[88,121],"for":[89,122],"83.2%":[90],"all":[92],"modifications.":[93],"Among":[94],"three":[96],"highest-contributing":[97],"PMAs,":[98],"inter-supplement":[100],"intervals":[101],"11,":[103],"12,":[104],"22.5":[106],"days.":[107],"Most":[108],"used":[109],"30-Day":[110],"Notice":[111],"(56.3%)":[112],"or":[113,118],"Real-Time":[114],"(17.3%).":[116],"Process":[117],"manufacturing":[119],"changes":[120,129],"61.4%":[123],"supplements,":[125],"followed":[126],"by":[127],"design":[128],"(24.6%).":[130],"From":[131],"2005\u20132025,":[132],"93":[133],"recalls":[134],"occurred,":[135],"91":[136],"(97.8%)":[137],"involving":[138],"stimulators;":[141],"87.1%":[142],"Class":[144],"II":[145],"recalls.":[146],"Extensive":[147],"postmarket":[148],"modification":[149],"high-risk":[151],"concentrated":[156],"in":[157,185],"small":[159],"number":[160],"implantable":[162],"occurred":[167],"mainly":[168],"requiring":[172],"new":[173],"clinical":[174],"data.":[175],"These":[176],"findings":[177],"underscore":[178],"importance":[180],"interpreting":[182],"marketed":[183],"context":[187],"complete":[190],"histories.":[192]},"counts_by_year":[],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2026-10-29T00:00:00"}
