Vectris™ 977D260 (UDI 00763000324315)Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00763000324315), received between Aug 31, 2022 and Aug 17, 2026 — classified as 17 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

9 other recalls cover devices cleared under the same FDA submission (P840001); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Impedance Problem

  Information was received from a distributor regarding a patient who was implanted with an implantable neurostimulator (INS) for unknown indications for use. It was reported that the electric resistance was abnormal. A replacement was guaranteed. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50285145 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SPINAL CORD STIMULATOR TRIAL WAS PERFORMED USING THE LEAD 977D260 TRIAL 5 MM COMPACT 1 X 8, AND THE TRIAL LEAD WAS REMOVED AFTER THE TRIAL; HOWEVER, DURING A LATER PLANNED PERMANENT SPINAL CORD STIMULATOR IMPLANT PROCEDURE, AN INTRAOPERATIVE X-RAY SHOWED THAT PART OF THE TRIAL LEAD HAD BEEN RETAINED IN THE PATIENT¿S BACK. THE PATIENT HAD PREVIOUSLY UNDERGONE MAGNETIC RESONANCE IMAGING FOR PRE-SURGICAL PLANNING, WAS EVALUATED BY A NEUROSURGEON, AND WAS SCHEDULED FOR THE PERMANENT IMPLANT. WHEN THE RETAINED FRAGMENT WAS IDENTIFIED IN THE OPERATING ROOM, IT WAS DECIDED TO REMOVE THE RETAINED TRIALLEAD FRAGMENT AND POSTPONE THE PERMANENT IMPLANT TO ALLOW HEALING. APPROXIMATELY 28 CM OF LEAD WAS REMOVED, AND PICTURES AND X-RAYS WERE TAKEN. THE REMOVED LEAD WAS RETAINED BY THE HOSPITAL AND SUBMITTED TO ITS RISK ANALYSIS DEPARTMENT. THE PATIENT REPORTEDLY DID NOT COMPLAIN OF ANY ADVERSE REACTION AFTER THE EARLIER LEAD REMOVAL, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25458065 ↗
• MalfunctionMay 29, 2026Human-Device Interface Problem; Material Twisted/Bent

  THE CALLER WAS A MANUFACTURER REPRESENTATIVE (REP) AND THE REASON FOR THE CALL WAS TO GET INFORMATION ABOUT THE RETURN MAILER. THE CALLER REPORTED THAT DURING AN IMPLANT CASE A LEAD BENT TOO EASILY. WHEN THE LEAD CAME OUT OF THE NEEDLE IT BENT IN HALF BETWEEN THE 0 AND 1 ELECTRODE. THE CALLER STATED THAT THEY WERE NOT SURE IF THE PHYSICIAN WAS APPLYING TOO MUCH FORCE. THE CALLER STATED THAT THEY HAVE SEEN OTHER LEADS BEND AT THE NEEDLE HUB BUT THIS LEAD BENT MORE SEVERELY. THE CALLER WILL RETURN THE LEAD FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331268 ↗
• MalfunctionMar 23, 2026Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING AN INTERNAL DEVICE. REP SAID THE PRODUCT WAS OPENED AND THE MEDICAL DOCTOR NOTICED DEFECT WITH THE LEAD TIP CONTACT. TROUBLESHOOTING WAS NOT PERFORMED. THE LEAD WAS NOT IMPLANTED AND WOULD BE RETURNED. NO SYMPTOMS WERE REPORTED. REP ACKNOWLEDGED THEY WOULD SUBMIT NEW INFORMATION THEY BECAME AWARE OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665437 ↗
• MalfunctionDec 29, 2025Difficult to Insert; Difficult to Insert

  INFORMATION WAS RECEIVED REGARDING AN IMPLANTABLE DEVICE. THE DOCTOR SAID THE LEAD WOULD NOT PASS THROUGH THE NEEDLE. TROUBLESHOOTING WAS PERFORMED. WHEN IT WAS PASSED OFF THE FIELD IT WAS FOUND TO PASS THROUGH THE NEEDLE BUT THE PROVIDER WANTED IT EXAMINED ANYWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906910 ↗
• InjuryDec 18, 2025Break; Break

  IT WAS REPORTED THAT THE GUIDE WIRE TOOK THE TIP OF THE LEAD (PLASTIC PART) OFF WHEN HE WAS ADJUSTING THE LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838690 ↗
• InjuryNov 21, 2025Positioning Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE TO THE PHYSICIAN DUE TO NOT BEING ABLE TO PASS THE TRIAL LEAD PAST ADHESIONS OR SCAR TISSUE. THE PATIENT HAD ALSO GONE THROUGH A TRIAL BACK IN (B)(6) 2025 AND THE TRIAL WAS NOT COMPLETED AS THE LEADS CAME OUT OF THE EPIDURAL SPACE. THIS WAS A RE-TRIAL FOR THIS PATIENT. THE CAUSE WAS UNKNOWN. THE PHYSICIAN STATED THE ISSUE WAS DUE TO SCARRING OR ADHESIONS THAT WOULD NOT LET THE LEAD TO TREAD. THE PROCEDURE WAS THEN ABORTED. IN RECOVERY, THE PATIENT EXPRESSED SEVERE PAIN IN THE RIGHT THAT WAS NOT PRESENT PRIOR TO THE TRIAL PROCEDURE ATTEMPT. THE PHYSICIAN WAS NOTIFIED AND PRESCRIBED PAIN MEDICATION AND STEROID MEDICATION AND THE PATIENT WAS DISCHARGED FROM THE FACILITY TO GO HOME. THE PATIENT HAS A FOLLOW-UP APPOINTMENT ON (B)(6) 2025.

  Patient problems: Adhesion(s); Pain; Scar Tissue

  MAUDE report 23618805 ↗
• MalfunctionNov 14, 2025Difficult to Insert; Insufficient Device Problem Information; Difficult to Insert; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM A USER REPORT. IT WAS REPORTED THAT THE REASON THE SPINAL CORD STIMULATION LEAD WAS IMPLANTED UNDER DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) TO TREAT POSTHERPETIC NEURALGIA. THEY HAD BEEN DIAGNOSED WITH POSTHERPETIC NEURALGIA AFTER BEING ADMITTED WITH RIGHT THORACIC AND DORSAL POSTHERPETIC PAIN FOR 4 WEEKS. DURING THE PROCEDURE, IT WAS FOUND THAT THE DIAMETER OF THE PUNCTURE NEEDLE SHEATH DID NOT MATCH THAT OF THE LEAD, RESULTING IN THE INABILITY OF THE LEAD TO PASS THROUGH THE NEEDLE INTO THE EPIDURAL SPACE. AFTER REPLACING THE PUNCTURE NEEDLE, THE LEAD WAS ABLE TO ENTER NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553769 ↗
• MalfunctionAug 27, 2025Break; Device Damaged Prior to Receipt by User; Break; Device Damaged Prior to Receipt by User

  THE REP REPORTED THE DAMAGE TO THE LEAD WAS NOTED PRIOR TO USE IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903128 ↗
• MalfunctionAug 5, 2025Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THERE WAS A TEST LEAD FAILURE; THE LEAD PUNCTURE NEEDLE WAS FOUND TO BE BENT DURING THE OPERATION. THE BENT NEEDLE WAS NOTICED WHEN OPENING THE PACKAGING DURING THE SURGERY. THE LEAD KIT WAS REPLACED TO COMPLETE THE OPERATION THE SAME DAY; THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22722437 ↗
• MalfunctionJun 9, 2025Connection Problem; Connection Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). REP REPORTED THAT NEW IMPLANT LEADS WERE USED FOR REPLACEMENT BECAUSE THEY HAD A TRIAL BEFORE THIS ISSUE AND HAD USED ALL OF THE BACK-UP TRIAL LEADS. REP REPORTED RETUNNELING WAS NOT REQUIRED AND THE PROCEDURE WAS COMPLETED WITH IMPLANT LEADS. THE INFORMATION HAS BEEN CONFIRMED WITH THE PHYSICIAN. REP WILL RETURN THE LEADS FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168897 ↗
• MalfunctionMay 12, 2025Break; Break

  THE DEVICES WERE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003280 ↗
• MalfunctionApr 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A LEAD. THE REP REPORTED THEY OPENED THE LEAD KIT AND REALIZED IT WAS CRACKED AND NEVER PUT ON THE FIELD. THE CAUSE WAS UNKNOWN. NO PATIENT WAS INVOLVED WITH THE EVENT. THE PRODUCT WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866223 ↗
• InjuryMar 7, 2025Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). ATTEMPTED PLACEMENT, MD GOT A WET TAP AT T11/12 AND WAS UNABLE TO ACCESS EPIDURAL SPACE AT A HIGHER LEVEL DESPITE MULTIPLE ATTEMPTS. NO ACTION TAKEN/NO ADVERSE OUTCOME. THE ISSUE WAS RESOLVED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 21545687 ↗
• MalfunctionMar 3, 2025Break; Positioning Problem; Break; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTI MULATOR (INS). REP REPORTED A DIFFICULT LEAD PLACEMENT DUE TO A DAMAGED STYLET. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505445 ↗
• InjuryFeb 10, 2025Break; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Break; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE TRIAL LEAD STYLET PUSHED THROUGH THE TOP OF THE LEAD CAUSING A CONTACT TO BE LEFT IN THE PATIENT. THE TOP CONTACT FROM THE TRIAL LEAD BROKE OFF OF THE LEAD. THE DEVICE WOULD BE RETURNED. THE ISSUE WAS RESOLVED, AND A RE-TRIAL WAS ATTEMPTED OR PLANNED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349247 ↗
• MalfunctionNov 19, 2024Difficult to Insert; Difficult to Insert

  A DISTRIBUTOR REPORTED THAT THERE WAS A ¿LEAD FAILURE¿ WHEREBY THE ¿GUIDE WIRE COULD NOT BE INSERTED DURING THE SURGERY.¿ IT WAS STATED THAT SURGERY WAS COMPLETED ON THE SAME DAY WITH THE REPLACEMENT OF THE LEAD WITH A NEW LEAD AND THE ISSUE WAS RESOLVED. THE LEAD STATUS WAS REPORTED AS ¿NEVER IMPLANTED.¿ THERE WERE NO SURGICAL INTERVENTIONS PLANNED OR PERFORMED AND THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. NO COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727660 ↗
• MalfunctionNov 14, 2024Difficult to Insert; Difficult to Insert

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THERE WAS A TEST LEAD FAILURE. THE GUIDE WIRE COULD NOT BE PUT TO THE BOTTOM, ALSO STATED AS COULD NOT BE INSERTED. THE LEAD WAS REPLACED AND THE ISSUE WAS RESOLVED. NO SURGICAL INTERVENTION OCCURRED, NOR WAS PLANNED. PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685102 ↗
• MalfunctionOct 16, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL LEAD. IT WAS REPORTED THAT THE TRIAL LEAD WAS BENT, MAKING USE DIFFICULT. THE STYLET OF THE LEAD WAS CHANGED BUT THE ISSUE REMAINED. THE CAUSE IS UNKNOWN. THE LEAD WAS SENT BACK FOR ANALYSIS. THE ISSUE IS CONSIDERED RESOLVED AS THE LEAD WAS NOT USED IN THE CASE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. THE REP NOTED THEY WOULD SUBMIT ANY NEW INFORMATION THAT BECOMES AVAILABLE. ON (B)(6) 2024 THE REP REPORTED IT IS UNKNOWN IF THE LEAD WAS BENT OUT OF BOX (OOB). THE STYLET WAS REMOVED, REPLACED, AND ISSUE REMAINED. THE TRIAL LEAD WAS ATTEMPTED FOR USE IN THE TRIAL, BUT WAS NEVER LEFT IN PATIENT. NO CONTRIBUTING FACTORS WERE DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20460798 ↗
• MalfunctionSep 26, 2024Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). REP REPORTED THAT THE LEAD WAS NOT USED AND A NEW LEAD KIT WAS OPENED AND USED FOR THE CASE. REP REPORTED THE ISSUE WAS RESOLVED AND THE BENT LEAD WAS DISCARDED.

  Patient problems: Stenosis

  MAUDE report 20311225 ↗
• MalfunctionAug 22, 2024Impedance Problem; Impedance Problem

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE ELECTRIC RESISTANCE COULD NOT BE DETECTED DURING SURGERY. THE LEAD WAS REPLACED WITH THE NEW TEST LEAD, THE ISSUE HAS RESOLVED, AND THE DEVICE WAS NOT IMPLANTED. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS STATED THAT THIS EVENT WAS AN INTRAOPERATIVE WIRE IMPEDANCE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20028331 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT (PT) HAD THEIR TRIAL LEAD IMPLANTED )(B)(6) 2024 AND IT WAS EXPLANTED (B)(6) 2024.  BY (B)(6) 2024, AN EPIDURAL ABSCESS HAD DEVELOPED.  THE PT WAS GIVEN ANTIBIOTICS.  THE TRIAL LEADS HAD BEEN DISCARDED.  ON THE DATE OF THE LEAD EXPLANT / LEAD PULL THE PT DID NOT REPORT ANY PROBLEM.  THE ISSUE WAS ONGOING AT THE TIME OF THE REPORT.  NO DEVICE ISSUE WAS REPORTED.

  Patient problems: Abscess

  MAUDE report 20007562 ↗
• MalfunctionMay 22, 2024Difficult to Remove; Insufficient Device Problem Information; Difficult to Remove; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THERE WAS A LEAD FAILURE. DURING THE SURGERY, IT WAS FOUND THAT THE MIDDLE GUIDE WIRE OF THE LEAD COULD NOT BE PULLED OUT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING WITH A NEW LEAD. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. IT WAS REPORTED THAT SURGICAL INTERVENTION DID NOT OCCUR NOR WAS IT PLANNED. THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375476 ↗
• InjuryMay 9, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT ACCIDENTLY PULLED THE TRIAL LEAD OUT. IT WAS PLANNED TO RE-TRIAL THE PATIENT. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279335 ↗
• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS USING TRIAL LEADS. IT WAS REPORTED THAT THE PATIENT (PT) WENT TO THE HOSPITAL WITH 10/10 LEG PAIN AFTER THE TRIAL, AND LEADS WERE PULLED RIGHT AFTER THE PT WOKE UP POST OP. THE PAIN CONTINUED SO PT WAS TRANSFERRED TO THE HOSPITAL. THE LEADS WERE RETURNED FOR ANALYSIS. THE REP WILL REPORT ADDITIONAL INFORMATION THAT BECOMES AVAILABLE. ON 2024-JAN-19 THE REP REPORTED THERE WAS NO WENS DEVICE USED.

  Patient problems: Pain

  MAUDE report 18635523 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P840001. One submission often covers many models, so check the product and lot details in each record.

• Z-0372-2025 · Sep 18, 2024 · Open, Classified
  Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
• Z-1691-2024 · Mar 28, 2024 · Open, Classified
  Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
• Z-0780-2024 · Dec 19, 2023 · Open, Classified
  Model A710 Intellis Clinician Programmer Application, version 2.0.97
• Z-2159-2021 · Jul 9, 2021 · Open, Classified
  Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
• Z-1926-2016 · May 3, 2016 · Terminated
  Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or li
• Z-1147-2015 · Jan 9, 2015 · Terminated
  The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or m
• Z-1524-2014 · Feb 27, 2014 · Terminated
  Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced
• Z-0278-2014 · Sep 30, 2013 · Terminated
  Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
• Z-1536-06 · Aug 2, 2006 · Terminated
  Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis