SPECIFY 39565-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994560322), received between Apr 16, 2018 and Mar 11, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT WHEN THEY GOT A BOSTON SCIENTIFIC IMPLANTED NEUROSTIMULATOR (INS), THE MEDTRONIC LEAD WAS NOT REPLACED. THE PT STATED THAT "ONE OF THE BOTTOM RIGHT LEADS WAS NO LONGER WORKING" AND THEIR LEAD(S) WERE GOING TO BE REPLACED. THE PT INQUIRED ABOUT OTHER MEDTRONIC SYSTEMS. THEY WERE REDIRECTED TO SEE THEIR DOCTOR TO DISCUSS STIMULATOR OPTIONS FOR THEM. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573591 ↗
• MalfunctionOct 4, 2023Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Connection Problem; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Connection Problem

  IT WAS NOTED THE LEAD HAD BEEN IMPLANTED PAST THE USE BY DATE. THERE WERE NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17872919 ↗
• MalfunctionMar 28, 2023Contamination; Degraded; Difficult to Remove; Impedance Problem; Positioning Problem; Contamination; Degraded; Difficult to Remove; Impedance Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS REP WAS WITH THE PATIENT YESTERDAY DURING A NORMAL INS REPLACEMENT DUE TO NORMAL EOS, WHEN THE PATIENT'S RESIDENT AND PHYSICIAN HAD DIFFICULTY REMOVING THE LEAD TAILS FROM THE 37714. REP REPORTS THE RESIDENT WAS UNABLE TO PULL OUT THE LEADS FROM THE INS, THE PHYSICIAN TRIED AND WAS ABLE TO GET THEM OUT. BOTH THE RESIDENT AND THE PHYSICIAN ARE REPORTED TO HAVE INITIALLY THOUGHT THEY HAD THE WRONG WRENCH, BUT THEN LATER STATED TO REP THEY BELIEVED THE ENDS OF THE LEADS WERE CORRODED. REP STATES SHE DID NOT SEE THE CORROSION. REP REPORTS WHEN THE 97715 WAS PLACED, THE PHYSICIAN AND RESIDENT ALSO HAD DIFFICULTY PLACING THE LEADS INTO THE INS, BUT WERE ABLE TO CONNECT THEM. TROUBLESHOOTING WAS NOT REQUIRED. TECHNICAL. TECHNICAL SERVICES (TS) OBTAINED INFORMATION AND PROVIDED REP WITH THE CASE NUMBER. REP REPORTS THEY PLAN TO FILL OUT THE SCREEN FORM AND SEND THE INS IN TO MANUFACTURE FOR ANALYSIS.  ADDITIONAL INFORMATION WAS RECEIVED STATING REP REPORTS THEY ASSISTED WITH A NORMAL BATTERY REPLACEMENT YESTERDAY FROM A 37714 TO A 97715. REP REPORTS SH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632516 ↗
• MalfunctionMar 10, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FAILED BACK SURGERY SYNDROME AND SPINAL PAIN. IT WAS REPORTED THAT THE LAST SURGERY THEY HAD WITH THEIR DOCTOR THE INS WAS TAKEN OUT. PT STATED THAT HEALTH CARE PROVIDER (HCP) RETIRED, SO THEY HAD A DIFFERENT NEUROSURGEON NOW. PT STATED THAT THEY ARE HAVING A CAT SCAN DONE ON FRIDAY AS THEY WERE GETTING ELECTRICAL CURRENT THAT WENT FROM THE MIDDLE OF THEIR CHEST, UNDER THEIR BREAST, TO THEIR SHOULDER BLADE IN THEIR BACK AND PARTLY UNDER THEIR ARM. PT STATED THAT THE FEELING COMES AND GOES INTERMITTENTLY, HOWEVER THIS MORNING IT WAS THERE SINCE BEFORE NINE O'CLOCK AND IT WAS GETTING PRETTY PAINFUL. PT STATED THAT THE INS WAS REMOVED ON (B)(6) 2018. PT STATED THAT THE LEAD WAS NOT REMOVED AS THE LEAD WAS ATTACHED, SO HCP DIDN'T WANT TO MESS WITH THE LEAD. PT STATED THAT THEY WENT TO SEE DR. (B)(6) OVER A YEAR AGO AND THAT HCP'S PA SAID THAT SINCE THERE WAS NOT AN INS BATTERY IMPLANTED THEY DIDN'T KNOW HOW TO HELP THEM. PT STATED THAT THEY WENT TO THEIR PRIMARY CARE DOCTOR FOR AN EKG AND X-RAYS AND THAT EVERYTHING LOOKED FINE AND THAT HCP DIDN'T KNOW WHAT COULD BE CAUSING THE ISSUE.

  Patient problems: Electric Shock; Pain; Undesired Nerve Stimulation

  MAUDE report 13723867 ↗
• MalfunctionFeb 23, 2021Difficult to Remove; Connection Problem; Difficult to Remove; Connection Problem

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT CAME IN FOR A ROUTINE BATTERY REPLACEMENT DUE TO BATTERY BEING AT ELECTIVE REPLACEMENT INDICATOR (ERI). ONCE THE POCKET WAS OPENED UP THE SCREWS IN THE BATTERY WERE LOOSEN UP AND THE TOP LEAD WAS REMOVED BUT THE BOTTOM LEAD WAS UNABLE TO BE REMOVED UNTIL THE PHYSICIAN DISASSEMBLED THE OLD BATTERY. THE HCP DECIDED TO CHECK THE LEAD IMPEDANCE WITH A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS) VS GETTING IT STUCK IN THE NEW BATTERY AND ALL IMPEDANCE REMAINED WITHIN NORMAL LIMITS. NEXT THE PHYSICIAN ATTEMPTED TO PUT THE LEAD INTO AN EXTENSION BUT THE LEAD WAS ALSO UNABLE TO BE INSERTED INTO THE EXTENSION SO THE PHYSICIAN DECIDED TO REPLACE THE ENTIRE LEAD. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11367187 ↗
• MalfunctionJan 21, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT IMPLANTED FOR FAILED BACK SURGERY SYNDROME AND SPINAL PAIN. THE PATIENT REPORTED THAT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS ALREADY REMOVED, HOWEVER SOME PARTS OF THE LEAD WERE STILL IMPLANTED BECAUSE IT IS NOT FUNCTIONING. THEY NOTED THAT THE PROCEDURE WAS DONE IN (B)(6) 2013, BUT THE PATIENT COULD NOT RECALL THE EXACT DATE. NO FURTHER COMPLICATIONS OR PATIENT SYMPTOMS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9611553 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE LEAD WAS CONNECTED TO A COMPETITOR'S INS AND WAS EXPLANTED DUE TO LACK OF RELIEF. THE CAUSE WAS NOT DETERMINED. THE LEAD WAS DISCARDED. THE ISSUE WAS REPORTED TO BE RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 8428703 ↗
• InjuryApr 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT HAD THEIR INS EXPLANTED ON (B)(6) 2017 TO SWITCH OVER TO A COMPETITOR¿S DEVICE. IT WAS NOTED THAT THE INS WAS REMOVED, BUT THE PADDLE LEAD WAS LEFT IN AND THE PATIENT STARTED A TRIAL WITH THE COMPETITOR¿S INS THE SAME DAY. THE PATIENT ENDED UP GETTING A SEVERE STAPH INFECTION AND THE PATIENT WAS GETTING ALLERGY TESTING BECAUSE THEY HAD RASHES ALL OVER THEIR BACK. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

  Patient problems: Bacterial Infection; Rash

  MAUDE report 7433055 ↗

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