Stimulator, spinal-cord, totally implanted for pain relief
FDA product code LGW · Class 3 · 357 devices · 219,394 reports · 1,330 deaths reported · 24 devices named in recalls
- Octrode™ 3186St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF30 deaths32,096 reports
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths23,976 reports
- RestoreSensor™SureScan® 97714Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF6 deaths17,903 reports
- Proclaim™ 3660St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 recalls25 deaths13,336 reports
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF11,487 reports
- Precision Spectra ™ SC-1132Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF53 deaths11,269 reports
- Proclaim™ 5 EliteSt. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall10 deaths9,661 reports
- Proclaim™ 7 EliteSt. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall12 deaths7,299 reports
- Spectra WaveWriter™ SC-1160Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF31 deaths7,221 reports
- Precision™ SC-1110-02Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF26 deaths6,519 reports
- Penta™ 3228St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF11 deaths5,201 reports
- Eon Mini™ 3788St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death4,666 reports
- WaveWriter Alpha™ SC-1232Boston Scientific Neuromodulation Corporation · Stimulator, spinal-cord, totally implanted for pain relief1 recall41 deaths4,347 reports
- Precision™ Montage™ MRI SC-1200Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF22 deaths4,316 reports
- RestoreSensor 37714Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death4,116 reports
- Prodigy MRI™ 3772St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths3,162 reports
- Linear™ ST SC-2218-50Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2,729 reports
- PrimeAdvanced® SureScan® 97702Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death2,263 reports
- WaveWriter Alpha™ 16 SC-1216Boston Scientific Neuromodulation Corporation · Stimulator, spinal-cord, totally implanted for pain relief1 recall29 deaths2,190 reports
- Octrode™ 3189St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF8 deaths2,238 reports
- Protégé MRI™ 3771St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1,997 reports
- RestoreUltra® SureScan® 97712Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1,887 reports
- Senza® NIPG1500Nevro Corp. · Stimulator, Spinal-Cord, Totally Implanted For Pain Relief432 deaths1,792 reports
- Eterna™ 32400St. Jude Medical, Inc. · Stimulator, spinal-cord, totally implanted for pain relief1 recall5 deaths1,547 reports
- Omnia NIPG2500Nevro Corp. · Stimulator, Spinal-Cord, Totally Implanted For Pain Relief318 deaths1,532 reports
- Octrode® 3186Advanced Neuromodulation Systems, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths1,455 reports
- Swift-Lock™ 1192St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1,400 reports
- Proclaim™ 3670St. Jude Medical, Inc. · Stimulator, spinal-cord, totally implanted for pain relief2 recalls2 deaths1,253 reports
- Inceptiv™ 977119Medtronic, Inc. · Stimulator, spinal-cord, totally implanted for pain relief1,339 reports
- Infinion™ CX SC-2317-70Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall1 death1,268 reports
- Vanta™ AdaptiveStim™ 977006Medtronic, Inc. · Stimulator, spinal-cord, totally implanted for pain relief3 recalls1,151 reports
- Protégé™ 3789St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death1,226 reports
- Linear™ ST SC-2218-70Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1,175 reports
- Precision Novi™ SC-1140Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF10 deaths1,001 reports
- Infinion™ 16 SC-2316-50EBoston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF15 deaths978 reports
- Proclaim™ 3662St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 recalls1 death867 reports
- Infinion™ CX SC-2317-50Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall871 reports
- CoverEdge™ 32 SC-8336-50Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF802 reports
- Senza NIPG3000Nevro Corp. · Stimulator, Spinal-Cord, Totally Implanted For Pain Relief35 deaths722 reports
- Eon™ 3716Advanced Neuromodulation Systems, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF669 reports
- RestoreAdvanced® SureScan® 97713Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF632 reports
- Nevro NIPG2000Nevro Corp. · Stimulator, Spinal-Cord, Totally Implanted For Pain Relief134 deaths585 reports
- Octrode™ 3186St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF536 reports
- Inceptiv™ 977119Medtronic, Inc. · Stimulator, spinal-cord, totally implanted for pain relief513 reports
- Penta™ 3228Advanced Neuromodulation Systems, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF489 reports
- PrimeADVANCED™ 37702Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF451 reports
- Artisan™ SC-8216-50Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF451 reports
- Protégé™ 3789St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF446 reports
- Avista™ MRI SC-2408-56Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF441 reports
- NA 3383St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths439 reports
- Artisan™ SC-8216-70Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF424 reports
- CoverEdge™ 32 SC-8336-70Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death386 reports
- Eon C™ 3688St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths349 reports
- Infinion™ 16 SC-2316-50Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF343 reports
- Lamitrode® 3286Advanced Neuromodulation Systems, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF332 reports
- Evoke® Closed-Loop Stimulator (CLS) 3042Saluda Medical Pty Limited · Stimulator, Spinal-Cord, Totally Implanted For Pain Relief322 reports
- Resilience 55BIOTRONIK SE & Co. KG · Stimulator, spinal-cord, totally implanted for pain relief320 reports
- Linear™ 3-4 SC-2352-70Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF313 reports
- Penta™ 3228St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death303 reports
- Intellis™ Pro 977118Medtronic, Inc. · Stimulator, spinal-cord, totally implanted for pain relief1 death297 reports
- Proclaim™ 5St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall223 reports
- Lamitrode Tripole™ 3219Advanced Neuromodulation Systems, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death270 reports
- Linear™ 3-4 SC-2352-50Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF268 reports
- RestoreULTRA™ 37712Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF249 reports
- Exclaim™ 3225St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death246 reports
- PrimeAdvanced® SureScan® MRI 97702Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF242 reports
- Proclaim™ 3672St. Jude Medical, Inc. · Stimulator, spinal-cord, totally implanted for pain relief2 recalls121 reports
- Nevro® LEAD1058-70BNevro Corp. · Stimulator, Spinal-Cord, Totally Implanted For Pain Relief2 deaths211 reports
- Linear™ 3-6 SC-2366-70Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF202 reports
- Lamitrode Tripole™ 3219St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death201 reports
- Octrode™ 3189St. Jude Medical, Inc. · Stimulator, spinal-cord, totally implanted for pain relief197 reports
- Prospera IPGBIOTRONIK SE & Co. KG · Stimulator, spinal-cord, totally implanted for pain relief192 reports
- Eon Mini™ 3788St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF191 reports
- Nevro® TLEAD1058-50BNevro Corp. · Stimulator, Spinal-Cord, Totally Implanted For Pain Relief6 deaths173 reports
- NA 3341St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF165 reports
- Linear™ 3-6 SC-2366-50Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF157 reports
- Infinion™ 16 SC-2316-70Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF149 reports
- NA 2321St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF147 reports
- Clik™ X SC-4318Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall97 reports
- Nevro® LEAD1058-50BNevro Corp. · Stimulator, Spinal-Cord, Totally Implanted For Pain Relief2 deaths145 reports
- Senza LEAD1058-50BPNevro Corp. · Stimulator, Spinal-Cord, Totally Implanted For Pain Relief145 reports
- Vanta™ AdaptiveStim™ 977006Medtronic, Inc. · Stimulator, spinal-cord, totally implanted for pain relief1 recall94 reports
- Prodigy™ 3799St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF142 reports
- Avista™ MRI SC-2408-74Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF139 reports
- Evoke® CAP12 Percutaneous Lead Kit - 60 cm 3008Saluda Medical Pty Limited · Stimulator, Spinal-Cord, Totally Implanted For Pain Relief138 reports
- Vanta™ AdaptiveStim™ 977006Medtronic, Inc. · Stimulator, spinal-cord, totally implanted for pain relief135 reports
- Linear™ ST SC-2218-50EBoston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths135 reports
- Surpass™ LEAD3005-50BNevro Corp. · Stimulator, Spinal-Cord, Totally Implanted For Pain Relief133 reports
- TriCentrus™ 3292St. Jude Medical, Inc. · Stimulator, spinal-cord, totally implanted for pain relief127 reports
- Surpass™ LEAD3005-70BNevro Corp. · Stimulator, Spinal-Cord, Totally Implanted For Pain Relief1 death121 reports
- Proclaim™ 7St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall1 death69 reports
- Cinch™ 1194St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF118 reports
- Artisan™ MRI SC-8416-50Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF108 reports
- RestoreADVANCED™ 37713Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF106 reports
- NA 2311St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF102 reports
- Quattrode® 3146Advanced Neuromodulation Systems, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF101 reports
- Eon™ 3851Advanced Neuromodulation Systems, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF101 reports
- N/A A71100Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 recalls0 reports
- N/A 9772501Medtronic, Inc. · Stimulator, spinal-cord, totally implanted for pain relief95 reports
- NA 97725Medtronic, Inc. · Stimulator, spinal-cord, totally implanted for pain relief94 reports