Linear™ 3-6 SC-2366-50Recalls & reported problems
Boston Scientific Neuromodulation Corporation · 50cm 8 Contact Lead Kit · Class 3 · Implant
All models of Linear 3-6 (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Boston Scientific Linear spinal cord stimulator lead is implanted to deliver pain-relief stimulation. Many reports describe leads that migrated out of place, inadequate pain relief, and high electrical resistance, often leading to revision surgery. The 158 reports include no deaths and 150 injuries. No recalls name this device, and reports fell from 24 in the prior 12 months to 3 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 157
- Deaths reported
- 0
- Injuries reported
- 149
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 08714729789574), received between Feb 9, 2017 and Dec 18, 2025 — classified as 149 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Unexpected Therapeutic Results” (72 reports).
17 other recalls cover devices cleared under the same FDA submission (P030017); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Unexpected Therapeutic Results72
- Migration52
- Adverse Event Without Identified Device or Use Problem49
- High impedance19
- Fracture5
- Inappropriate/Inadequate Shock/Stimulation4
- Charging Problem1
- Defective Device1
Patient problems
- Pain37
- Inadequate Pain Relief35
- No Code Available32
- No Clinical Signs, Symptoms or Conditions25
- Discomfort24
- Erosion15
- Undesired Nerve Stimulation11
- Bacterial Infection7
Recent adverse event reports
The 25 most recent of 157 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2025High impedance; High impedance
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH TWO OF THE FOUR IMPLANTED LEADS WERE EXPLANTED AND REPLACED DUE TO HIGH IMPEDANCE READINGS. IT WAS NOT ABLE TO BE OBTAINED WHICH TWO OF THE FOUR LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23843479 ↗InjuryNov 13, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED PER HOSPITAL POLICY.
Patient problems: Pain
MAUDE report 23543242 ↗InjuryOct 30, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AS ONE OF THE SPINAL CORD STIMULATION (SCS) LEADS WAS NOT AS EFFECTIVE IN HELPING WITH THE PATIENTS PAIN. THE PATIENT ALSO HAD A NEW PAIN IN A DIFFERENT LOCATION AND THEREFORE THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE ONE OF THE IMPLANTED LEADS WAS REMOVED AND TWO NEW LEADS WERE IMPLANTED IN ORDER TO GET BETTER COVERAGE. THE NEW LEAD WAS IMPLANTED CLOSE TO WHERE THE EXPLANTED LEAD WAS BUT SLIGHTLY DIFFERENT AREA SO AS TO COVER THE PAIN AREA. IT IS UNKNOWN WHICH ONE OF THE THREE IMPLANTED LEADS WAS THE ONE THAT WAS REMOVED. POST OPERATIVELY, THE PATIENT WAS DOING WELL. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS DISPOSED BY THE MEDICAL FACILITY.
Patient problems: Pain
MAUDE report 23432695 ↗InjuryAug 25, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION FROM THE SPINAL CORD STIMULATOR (SCS) SYSTEM AND UNDERWENT A LEAD REVISION PROCEDURE IN WHICH ONE LEAD WAS REMOVED, AND TWO NEW LEADS ADDED. IT IS UNKNOWN WHICH OF THE TWO PREVIOUSLY IMPLANTED LEADS WAS EXPLANTED. THE PATIENT IS DOING WELL POST OPERATIVELY. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS DISPOSED OF PER HOSPITAL POLICY.
Patient problems: Pain
MAUDE report 22889522 ↗InjuryAug 9, 2025High impedance; Off-Label Use; High impedance; Off-Label Use
IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE REPLACED DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD AND LEAD EXTENSION REVISION PROCEDURE, WHEREIN TWO LEADS AND TWO LEAD EXTENSIONS WERE EXPLANTED AND REPLACED. THE DEVICES WERE RETAINED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS PROVIDED WITH SEVERAL DISCHARGE OPTIONS FOLLOWING THE PROCEDURE. COVERAGE WAS ACHIEVED IN BOTH UPPER EXTREMITIES, INCLUDING AREAS WITH OVERLAPPING PARESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22767516 ↗InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION ON A SUTURE SITE AT THE SPINAL CORD STIMULATION (SCS) LEAD INSERTION SITE. THE WOUND OF THE LEAD INSERTION SITE HAD NOT CLOSED, AND THE SITE WAS VISIBLY WET. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT A PROCEDURE WHERE THE SCS LEAD WAS REMOVED, AND A NEW LEAD WAS IMPLANTED AT A DIFFERENT POSITION. POST OPERATIVELY, THE PATIENT WAS DOING WELL, AND THE PATIENT IS EXPECTED TO FULLY RECOVER. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS CONTAMINATED. THE PHYSICIAN DOES NOT BELIEVE THAT THE INFECTION WAS DEVICE, STIMULATION OR PROCEDURE RELATED. CULTURES WERE NOT TAKEN.
Patient problems: Impaired Healing; Unspecified Infection
MAUDE report 22652540 ↗InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED AN INFECTION AT THE LEAD INSERTION WOUND SITE RESULTING IN REDNESS AROUND THE AREA IN THE LOW BACK. A CULTURE WAS TAKEN WHICH CONFIRMED THE PRESENCE OF STAPHYLOCOCCUS AUREUS. THE PATIENT WAS GIVEN ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE DURING WHICH THE SCS SYSTEM WAS REMOVED. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Patient problems: Bacterial Infection; Erythema
MAUDE report 22135107 ↗InjuryJun 3, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED SHOCKING SENSATIONS AT THE SITE OF THE SUBCUTANEOUS LEADS WHEN THE DEVICE WOULD BE ON. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE REPOSITIONED. THE PATIENT HAS RECOVERED, AND THE EVENT HAS RESOLVED.
Patient problems: Undesired Nerve Stimulation
MAUDE report 22134872 ↗InjuryMay 30, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION DUE TO LEAD MIGRATION THAT WAS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS MOVED BACK TO ITS ORIGINAL SPOT. THE LEAD REMAINS IMPLANTED, AND PATIENT WAS DOING WELL POSTOPERATIVELY.
Patient problems: Pain
MAUDE report 22113900 ↗InjuryMay 27, 2025Unexpected Therapeutic Results; Charging Problem; Migration; Unexpected Therapeutic Results; Charging Problem; Migration
IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A PROCEDURE DUE TO CHARGING DIFFICULTIES WITH THE IMPLANTABLE PULSE GENERATOR (IPG). ADDITIONALLY, THE LEADS MIGRATED, RESULTING IN INADEQUATE STIMULATION, WHICH PREVENTED THE PATIENT FROM EXPERIENCING SUFFICIENT PAIN RELIEF. THE PATIENT UNDERWENT AN IPG AND LEADS REVISION PROCEDURE WHEREIN THEIR IPG AND LEADS WERE EXPLANTED AND REPLACED. THE DEVICES WERE DISPOSED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING BETTER AND SATISFIED WITH THE NEW DEVICES. ELECTROCAUTERY WAS USED.
Patient problems: Pain
MAUDE report 22093064 ↗InjuryMay 20, 2025High impedance; Unexpected Therapeutic Results; Migration; High impedance; Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION, AND THE SPINAL CORD STIMULATION LEAD PLACED ON THE RIGHT SIDE, DISPLAYED HIGH IMPEDANCES. AS SUCH, THE PATIENT UNDERWENT A PROCEDURE WHERE THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED; HOWEVER, DURING THE PROCEDURE, THE PHYSICIAN DISCOVERED BY X-RAY THAT THE SECOND LEAD ON THE LEFT HAD MIGRATED. THE PHYSICIAN REPLACED THAT LEAD AS WELL. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE LEADS WERE NOT RETURNED AS THEY WERE RETAINED BY THE CUSTOMER.
Patient problems: Pain
MAUDE report 22058035 ↗InjuryApr 16, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNCOMFORTABLE SPIKY SENSATION IN HER BACK. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.
Patient problems: Undesired Nerve Stimulation
MAUDE report 21852048 ↗InjuryApr 15, 2025Unexpected Therapeutic Results; Use of Device Problem; Unexpected Therapeutic Results; Use of Device Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE SPINAL CORD STIMULATION (SCS) AS THE INITIAL LEAD PLACEMENT DID NOT ALIGN WITH THE PAIN AREA. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEADS WERE REPLACED AND CORRECTLY POSITIONED. THERE WERE NO REPORTED PATIENT ISSUES POSTOPERATIVELY.
Patient problems: Pain
MAUDE report 21845615 ↗InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD ON THE ARM WAS TOO CLOSE TO THE SURFACE OF THE SKIN AND WAS CAUSING PAIN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE SCS LEAD WAS REPOSITIONED DEEPER. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE LEADS REMAIN IMPLANTED.
Patient problems: Implant Pain
MAUDE report 21751746 ↗InjuryMar 14, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE SPINAL CORD STIMULATION AND A RETURN OF PAIN SYMPTOMS DUE TO LEAD MIGRATION, AS CONFIRMED THROUGH IMAGING. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE, THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE TWO LEADS WERE EXPLANTED AND REPLACED WITH NEW LEADS, DUE TO PHYSICIAN PREFERENCE. THERE WERE NO TECHNICAL ISSUES WITH THE LEADS. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE LEADS WILL NOT BE RETURNED THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Patient problems: Pain
MAUDE report 21610901 ↗InjuryMar 10, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS RELOCATED TO IMPROVE THE COVERAGE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Patient problems: Pain
MAUDE report 21558514 ↗InjuryFeb 21, 2025Migration; Migration
IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO LEAD MIGRATION AND AN UPGRADE OF THE IMPLANTABLE PULSE GENERATOR (IPG) TO NEW TECHNOLOGIES, REPLACEMENT WENT AS PLANNED. THE DEVICE WILL NOT RETURN BECAUSE IT WAS RETAINED BY FACILITY. THE PATIENT IS HAPPY AND FEELS GOOD POST OPERATIVELY. ELECTROCAUTERY WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21437546 ↗InjuryFeb 3, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED NEW PAIN IN HER LEFT ANTERIOR THIGH AND GROIN, WHICH STARTED A FEW DAYS FOLLOWING A RECENT REVISION SURGERY (SEE MFG 3006630150-2024-06199). THE PATIENT EXPRESSED THAT THE PAIN FELT LIKE A HOT WIRE, CAUSING INTENSE SORENESS, NUMBNESS, AND BURNING SENSATION. THE PATIENT FELT THE PAIN WHEN THE STIMULATION WAS BOTH ON OR OFF. X-RAY IMAGING REVEALED THAT THE SPINAL CORD STIMULATION (SCS) LEAD MIGRATED. THE PHYSICIAN WOULD HAVE RECOMMENDED A LEAD REVISION, BUT DUE TO THE NEW PAIN, HE SUSPECTS A POTENTIAL ISSUE WITH ONE OF HER LUMBAR DISCS AND HAS RECOMMENDED A MAGNETIC RESONANCE IMAGING (MRI) FOR FURTHER EVALUATION. CONSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE PATIENTS TWO PERIPHERAL LEADS WERE EXPLANTED FOR MRI COMPATIBILITY. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. THE PATIENT IS RECOVERING AS EXPECTED.
Patient problems: Burning Sensation; Discomfort; Numbness; Pain
MAUDE report 21297733 ↗InjuryJan 24, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED STIMULATION IN A NON-TARGET AREA. IMAGING PERFORMED REVEALED THAT ONE OF THE PATIENTS FOUR SPINAL CORD STIMULATION (SCS) LEADS MIGRATED AND BECAME COILED TOWARD THE SPINAL CORD STIMULATION IMPLANTABLE PULSE STIMULATOR (IPG). IN ADDITION, THE PATIENT DEVELOPED A DARKENED SCAB THAT FORMED AT THE IPG SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEADS WERE REPLACED AND REPOSITIONED. THE SCAB AT THE IPG SITE WAS EXCISED DURING THE REVISION IN ORDER TO GAIN ACCESS TO THE BATTERY. THE PATIENT IS RECOVERING AS EXPECTED. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21231281 ↗InjuryDec 13, 2024Migration; Migration
IT WAS REPORTED THAT THE LEAD MIGRATED WHICH WAS CONFIRMED THROUGH IMAGING. THE PATIENT UNDERWENT A PROCEDURE WHERE THE INTENT WAS TO RE-POSITION THE LEAD INTO THE CORRECT POSITION, HOWEVER THE PHYSICIAN CUT THE LEAD AND THEREFORE ENDED UP REPLACING THE LEAD. POST OPERATIVELY, THE PATIENT WAS DOING WELL RECEIVING GOOD COVERAGE OF THEIR PAIN AREA. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY. IT IS UNKNOWN WHICH OF THE TWO IMPLANTED LEADS WAS THE ONE INVOLVED WITH THE EVENT AND WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20928738 ↗InjuryDec 11, 2024Migration; Migration
IT WAS REPORTED THAT ONE OF THE PATIENTS SPINAL CORD STIMULATION LUMBAR LEADS BECAME SUPERFICIAL. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE PHYSICIAN MADE A SMALL INCISION AND RE-BURIED THE LEAD. NO DEVICES WERE IMPLANTED OR EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT IS EXPECTED TO FULLY RECOVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20908663 ↗InjuryDec 1, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF FROM THEIR SPINAL CORD STIMULATION (SCS) SYSTEM. X-RAY IMAGING PERFORMED CONFIRMED LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEADS WERE REPOSITIONED, AND SUTURE SLEEVES WERE ADDED FOR ANCHORING. THE PATIENT WAS RECOVERING WITHOUT COMPLICATION POSTOPERATIVELY AND WAS DISCHARGED SAME DAY.
Patient problems: Pain
MAUDE report 20815711 ↗InjuryDec 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) PERIPHERAL LUMBAR LEADS WERE CAUSING SEVERE PAIN AND DISCOMFORT IN HER LUMBAR REGION. THE PATIENT EXPERIENCED THE PAIN AND DISCOMFORT WHETHER THE SCS WAS ON OR OFF. IT IS THOUGHT THAT HER RARE SKIN CONDITION AND ANATOMY COULD BE CONTRIBUTING TO THIS. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE TWO SCS LEADS WERE EXPLANTED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY. THE PATIENT IS RECOVERING WITHOUT COMPLICATION AND WAS DISCHARGED SAME DAY.
Patient problems: Discomfort; Pain
MAUDE report 20815520 ↗InjuryNov 22, 2024Migration; Migration
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED SENSITIVITY AND DISCOMFORT AT ONE OF HER TWO IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITES AND UNDERWENT A REVISION PROCEDURE (REPORTED IN MFR# 3006630150-2024-08047). DURING THE PROCEDURE IT WAS FOUND THAT THE LEADS FROM BOTH SYSTEMS HAD BECOME ENTANGLED. AS A RESULT, THE LEADS WERE REMOVED; AND DUE TO THE FACT THAT THE PHYSICIAN FELT THAT THERAPY NEEDS COULD BE ACCOMPLISHED WITH ONE SYSTEM THE IPG WAS ALSO REMOVED. THE PATIENT DID WELL POSTOPERATIVELY. IT WAS NOTED THAT THE PATIENT WORE A COMPRESSIVE GIRDLE, AND THE ACT OF PUTTING IT ON AND WEARING IT THE FULL DAY APPEARED TO HAVE PUSHED DOWN ON THE IPG WHICH MAY HAVE CAUSED THE DEVICES TO MOVE.
Patient problems: Discomfort; Pain
MAUDE report 20755115 ↗InjuryNov 8, 2024Unexpected Therapeutic Results; Defective Device; Migration; Unexpected Therapeutic Results; Defective Device; Migration
IT WAS REPORTED THE PATIENT EXPERIENCED LOSS OF PAIN COVERAGE. THE PATIENT FELL ONTO HER BACK AND SUBSEQUENTLY THE CLUNEAL SPINAL CORD STIMULATION LEADS MIGRATED. THE PHYSICIAN STATED THAT THE LEAD APPEARED TO BE FRACTURED, HOWEVER THERE WAS NO X-RAY IMAGING PERFORMED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEADS WERE REPLACED. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY.
Patient problems: Pain
MAUDE report 20645860 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P030017. One submission often covers many models, so check the product and lot details in each record.
- Z-2879-2026 · Jun 17, 2026 · Open, ClassifiedINFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spin
- Z-2404-2026 · Apr 29, 2026 · Open, ClassifiedBoston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
- Z-2617-2024 · Jul 17, 2024 · Open, ClassifiedWAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
- Z-2122-2020 · Apr 24, 2019 · TerminatedThe LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic i
- Z-2119-2020 · Apr 24, 2019 · TerminatedArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left
- Z-2120-2020 · Apr 24, 2019 · TerminatedThirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Devic
- Z-2124-2020 · Apr 24, 2019 · TerminatedFifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Gene
- Z-2121-2020 · Apr 24, 2019 · TerminatedLinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electric
- Z-2123-2020 · Apr 24, 2019 · TerminatedPrecision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in
- Z-1409-2010 · Mar 19, 2010 · TerminatedBionic NAVIGATOR Clinician Programmer Model Number SC-7150-4
- Z-0271-2009 · Sep 22, 2008 · TerminatedPrecision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Po
- Z-1441-2012 · Apr 22, 2008 · TerminatedOMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractabl
- Z-0960-2008 · Oct 5, 2007 · TerminatedAdvanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342
- Z-0055-2008 · Aug 3, 2007 · TerminatedPrecision Implantable Pulse Generator (IPG), Model Number SC-110
- Z-0700-2007 · Jan 30, 2007 · TerminatedThe Precision Implantable Pulse Generator, Model Number SC-1110
…and 2 more.
Other STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF devices
- 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
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page