RestoreUltra® SureScan® 97712Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,887 adverse event reports that list this exact device (DI 00643169109506), received between Dec 22, 2014 and Aug 18, 2026 — classified as 620 injuries, 1,267 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (572 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 25 most recent of 1,887 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Charging Problem; Connection Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50294326 ↗
• MalfunctionMay 28, 2026Improper or Incorrect Procedure or Method; Battery Problem; Charging Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). CALLER STATED THAT THE PATIENT'S STIMULATOR IS NON-FUNCTIONING. CALLER STATED THAT THEY WERE TOLD THE DEVICE STOPPED CHARGING OR FUNCTIONING ABOUT 5 YEARS AGO . AGENT REVIEWED NORMAL EOS EXPECTATION, POSSIBLE OVERDISCHARGE. AGENT REVIEWED OPTIONS FOR SCANNING THE PATIENT'S HEAD (MRI). THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25316779 ↗
• MalfunctionMay 27, 2026Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Battery Problem; Insufficient Device Problem Information

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

  Patient problems: Pain

  MAUDE report 25300941 ↗
• InjuryMay 18, 2026Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT A BATTERY REPLACEMENT PROCEDURE WITH A COMPETITIVE IMPLANTABLE PULSE GENERATOR WAS INITIATED AND THEN ABORTED AFTER IMAGING PERFORMED TO ASSESS LEAD PLACEMENT SHOWED POSSIBLE LEAD FRACTURE, WITH THE LEADS APPEARING FRACTURED ON IMAGING. THE LEADS WERE REPORTED TO BE NON-FUNCTIONAL WHEN CONNECTED TO TRIALING CABLES, AND STIMULATION ISSUES WERE REPORTED AS OCCURRING AS A RESULT OF THE ISSUE. THE ISSUE WAS REPORTED AS ONGOING AND NOT RESOLVED. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201868 ↗
• MalfunctionMay 12, 2026Failure to Interrogate; Improper or Incorrect Procedure or Method; Battery Problem; Communication or Transmission Problem; Insufficient Device Problem Information

  ADDITIONAL INFO RECEIVED FROM REP THAT THE ISSUE HAS BEEN RESOLVED.

  Patient problems: Pain

  MAUDE report 25145979 ↗
• InjuryApr 22, 2026Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM PATIENT'S REP REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR THE CALL WAS THAT THE PATIENT REP REPORTED THE PREVIOUS INS HAD MOVED AND WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955551 ↗
• MalfunctionApr 22, 2026Therapy Delivered to Incorrect Body Area; Inappropriate/Inadequate Shock/Stimulation; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED THEY USED TO GET SHOCKING DOWN THEIR LEGS AND A LITTLE BIT AROUND THEIR BODY BUT NOW THEY WERE ONLY GETTING SHOCKING RIGHT ON TOP OF THE IMPLANT OR ABOUT HALF AN INCH FROM THE IMPLANT. THE ISSUE BEGAN A MONTH AGO. PATIENT STATED THEY WENT TO A DOCTOR AND GOT A SHOT A COUPLE WEEKS AGO OR ABOUT A MONTH AND A HALF AGO. PATIENT WENT TO GET SHOTS AGAIN A SECOND TIME AND SINCE THEN THE SHOCKING WOULD NOT GO NOWHERE EXCEPT FOR THE IMPLANT. PATIENT ALSO INQUIRED IF IT WAS A POSSIBILITY FOR THEIR DOCTOR TO HIT THEIR LEADS WITH THE INJECTIONS. AGENT REVIEWED INFORMATION. PATIENT ALSO MENTIONED THEY MOVED AROUND A LOT AND WOULD BEND DOWN OR TWIST EXCESSIVELY AND WAS PRETTY ACTIVE. AGENT REVIEWED INFORMATION. THE ISSUE WAS NOT RESOLVED. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Electric Shock; Inappropriate Device Stimulation of Tissue

  MAUDE report 24953179 ↗
• InjuryApr 15, 2026Energy Output Problem; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT OUT OF REGULATION MESSAGE/SETTINGS NOT AVAILABLE, STIMULATION UNABLE TO BE ADJUSTED WAS SEEN. IT WAS NOTED THAT THE BATTERY WAS DISCHARGED AND UNABLE TO CONNECT, WITH THE CAUSE IDENTIFIED AS NORMAL END OF LIFE. THE IMPLANTABLE NEUROSTIMULATOR AND LEADS WERE EXPLANTED SUCCESSFULLY WITH NO ISSUES TO THE PATIENT, AND THE PHYSICIAN EXPRESSED CONCERN ABOUT A WHITE SUBSTANCE THAT CAME FROM THE IMPLANTABLE PULSE GENERATOR POCKET. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REASON FOR EXPLANT WAS DUE TO NORMAL END OF LIFE, THE PLAN WAS TO REPLACE THE ENTIRE SYSTEM. IT WAS ONLY EXPLANTED WHEN THE WHITE SUBSTANCE WAS DISCOVERED. SHE WILL BE RE-IMPLANTED AT A LATER DATE. THE PHYSICIAN DID A BLOOD CULTURE THAT CAME BACK NEGATIVE. THE PHYSICIAN DOES NOT BELIEVE ANY DEVICE MALFUNCTION OCCURRED. HE BELIEVES IT WAS A CALCIFICATION FLUID THAT ACCUMULATED IN THE POCKET.

  Patient problems: Calcium Deposits/Calcification; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886776 ↗
• MalfunctionApr 7, 2026Overheating of Device

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTED STIMULATOR (INS). CALLER REPORTED THEY ARE EXPERIENCING BURNING WHERE THE INS IS IMPLANTED ON THEIR LEFT SIDE ABOVE THEIR BUTTOCK. CALLER REPORTED THIS STARTED ABOUT 3 WEEKS AGO. CALLER STATED THEY WENT THE ER WHEN THEY FIRST FELT THE BURNING BUT WERE TOLD THAT THEY DON'T DEAL WITH IMPLANTS. CALLER ALSO STATED THEY WENT TO ANOTHER ONE OF THEIR PROVIDERS BUT WERE REDIRECTED BACK TO THEIR IMPLANTING PROVIDER WHO HAS SINCE RETIRED. AGENT OFFERED TO SEND HCP LISTINGS TO THE PATIENT VIA MAIL PER REQUEST AND RECOMMENDED PATIENT SEEK MEDICAL ATTENTION IF NECESSARY. CALLER REPORTED HISTORICAL INFORMATION THAT THE STIMULATOR "SOMEHOW HAD A PROBLEM" AND THEY THINK IT WAS REPLACED BUT THEY CANNOT RECALL. CALLER STATED THEY HAVE TRIED FOR YEARS TO FIND A PROVIDER TO HELP WITH THEIR SPINAL CORD STIMULATOR (SCS) BUT CANNOT FIND ANYONE. CALLER SAID THE SCS DOES NOT WORK ANYMORE AND WILL NOT RECHARGE. CALLER STATES THIS ISSUE STARTED TO GET WORSE AROUND "COVID-TIME". CALLER SAID THEY CALLED SOMEONE A FEW YEARS AGO AND TRIED TO TROUBLESHOOT WITH THE EXTERNAL EQUIPMENT BUT THE ISSUE WAS NOT RESOLVED.

  Patient problems: Burning Sensation

  MAUDE report 24805769 ↗
• MalfunctionApr 3, 2026High impedance

  IT WAS REPORTED THAT HIGH IMPEDANCE WERE OBSERVED ON ELECTRODES DURING INTERROGATION AND CONNECTION CHECKS. A CONNECTION CHECK AND IMPEDANCE CHECK WERE PERFORMED ON THE PRIOR BATTERY AND SHOWED HIGH IMPEDANCES, 40 ,000. THE PATIENT USED A PROGRAM UTILIZING THE ELECTRODES WITH HIGH IMPEDANCE AND REPORTED ADEQUATE PAIN RELIEF. WHEN THE SYSTEM WAS CONNECTED TO A NEW BATTERY, THE SAME ELECTRODES AGAIN DISPLAYED HIGH IMPEDANCE. TROUBLESHOOTING WAS PERFORMED BY RE-INSERTING THE LEAD INTO THE BATTERY TO DETERMINE WHETHER THE HIGH IMPEDANCE WOULD CLEAR, BUT THE HIGH IMPEDANCE DID NOT RESOLVE AND THE ISSUE REMAINED ONGOING. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776686 ↗
• MalfunctionMar 16, 2026Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT CALLER HAD A BROKEN DESKTOP CHARGER CONNECTOR PIN. A REQUEST WAS SENT TO REPAIR TO REPLACE THE DESKTOP CHARGER. DURING THE CALL, CALLER MENTIONED THAT THIS ISSUE HAD HAPPENED BEFORE AND THAT THEY HAD CALLED MANY TIMES BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603703 ↗
• InjuryMar 5, 2026Failure to Interrogate; Battery Problem; Charging Problem; Communication or Transmission Problem

  PATIENT TRIED BUT COULDN'T RECHARGE HER IMPLANT, IT KEPT SHOWING REPOSITION ANTENNA. PATIENT SAID SHE HASN'T USED HER SYSTEM FOR ABOUT 2 MONTHS PRIOR TO TRYING TO RECHARGE. TECHNICAL SERVICES(TS) REDIRECTED PATIENT BACK TO HCP TO ADDRESS POSSIBLE OVERDISCHARGE. PATIENT CALLED BACK AND PATIENT MENTIONED THEIR UNIT DOES NOT COMMUNICATE WITH THEIR IMPLANT AND COULD NOT CHARGE THEIR IMPLANT. PATIENT MENTIONED THEIR HCP DON'T DEAL WITH MEDTRONIC AND WON'T USE THE PAGING NUMBER. AGENT REVIEWED ROLE OF PATS (NOT A SCHEDULING CENTER), ROLE OF MDT REP AND REVIEWED ROLE OF NAS. AS A COURTESY AGENT OFFERED TO SEND EMAIL TO NOTIFY THE FIELD. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED THE DOCTOR'S OFFICE INSISTED THEY CALL THEIR REPRESENTATIVE (REP) SO THE PATIENT CALLED AND LEFT A MESSAGE. THE REP STATED THE MOST LIKELY CAUSE OF THE EVENT WAS THE PATIENT'S BATTERY WAS AT THE END OF LIFE. THE PATIENT HAD AN APPOINTMENT WITH THEIR NEUROSURGEON TO GET THE UNIT REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520386 ↗
• MalfunctionMar 4, 2026Battery Problem; Charging Problem; Connection Problem; Material Integrity Problem

  PATIENT REP CALLED BACK SAYING THEY HADN'T RECEIVED THE REPLACEMENT DTC YET. AGENT REVIEWED EXPECTED SHIPPING TIMING FROM WHEN THE REQUEST WAS SUBMITTED ON MONDAY AND CONFIRMED WITH TRACKING NUMBER THAT PACKAGE SHOULD BE DELIVERED TODAY. AGENT PROVIDED TRACKING NUMBER TO CALLER. PATIENT REP (SEE INITIAL REPORTED) CALLED BACK AND CONFIRMED RECEIVING THE REPLACEMENT DTC. PATIENT REP MENTIONED THE PATIENT PLUGGED IN THE DTC AND GETS THE SAME ERROR MESSAGE. PATIENT REP DESCRIBED THE RECHARGER (INSR) WAS SHOWING CHARGE THE RECHARGER NOW SCREEN WHILE THE INSR WAS IN THE CHARGING CORD IN THE WALL. AGENT INSTRUCTED PATIENT REP TO PLUG THE DTC INTO ANOTHER OUTLET, PATIENT REP PRESSED THE GREEN BUTTON AND DESCRIBED THE RECHARGER SHOWED THE REPOSITION ANTENNA SCREEN THEN CHARGE THE RECHARGER NOW SCREEN. AGENT ASKED, PATIENT REP MENTIONED THE PATIENT LAST CHARGED THEIR IMPLANT ON FRIDAY AND PATIENT NOTED THE RECHARGER DOESN'T SHOW ANY BARS. PATIENT REP MENTIONED THE PATIENT LAST USED THE PATIENT PROGRAMMER SEVERAL YEARS AGO. PATIENT INSERTED NEW AAA BATTERIES INTO THE PATIENT PROGRAMMER, THEN PATIENT REP TRIED TO SYNC THE PATIENT PROGRAMMER TO THE IMPLANT AND THE PATIENT PROGRAMMER SHOWED GROU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506515 ↗
• InjuryMar 3, 2026Improper or Incorrect Procedure or Method; Battery Problem; Charging Problem

  IT WAS REPORTED THAT PATIENT LAST SUCCESSFULLY CHARGED IMPLANTABLE NEUROSTIMULATOR (INS) ABOUT 2-3 MONTHS AGO AND NOTICED THEY COULD NOT CHARGE ABOUT A MONTH AGO. AGENT REVIEWED OVERDISCHARGE AND REVIEWED HOW TO RESOLVE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496984 ↗
• InjuryMar 2, 2026Energy Output Problem; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT STATED THEY HAD GOTTEN BETTER SO THEY KIND OF QUIT USING THE STIMULATOR, BUT NOW THEY WERE TRYING TO USE THE PAIN STIMULATOR AGAIN. PATIENT SAID THEY COULD TURN STIM OFF USING THE PATIENT PROGRAMMER (PP), BUT THEY WOULD STILL FEEL THE BUZZING AND THE BUZZING WAS GETTING WORSE. AGENT ASKED IF THE BUZZING WAS THE SAME AS THE STIMULATION, PATIENT SAID IT WAS HARD TO SAY BUT THEY THOUGHT THE BUZZING FELT THE SAME AS THE STIMULATION. PATIENT ALSO SAID IF THEY WERE SITTING IN THE WRONG PLACE OR IF THEY LAY ON THEIR BACK, THE IMPLANT WAS PUSHING ON THEIR SI JOINT, AND WAS CAUSING A LOT OF PAIN. PATIENT MENTIONED THEY WERE 73 YEARS OLD AND HAD GAINED A FEW POUNDS, SO MAYBE THAT WAS PART OF IT. WHEN ASKED EVENT DATE, PATIENT SAID BOTH ISSUES STARTED PROBABLY WHEN THEIR SI JOINT GOT BAD, ABOUT 3-5 MONTHS AGO. PATIENT SAID THEY HAD AN INJECTION IN THEIR SI JOINT 3-4 WEEKS AGO AND THAT DOCTOR SAID SOMETIMES WITH THE OLDER DEVICES PATIENT HAS, THE DEVICE CAN DO THAT AND KEEP BUZZING. THE PATIENT SAID THEIR PREVIOUS DOCTOR PASSED AWAY AND THE PERSON HELPING THE PATIENT ON THE CALL ST

  Patient problems: Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 24485052 ↗
• MalfunctionFeb 27, 2026Failure to Interrogate; No Device Output; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT SAID THAT THE IMPLANT HAS NEVER HELPED THEIR PAIN SINCE IT WAS PUT IN. THEY SAID "IT NEVER EVEN TURNED ON ONCE, AND THEY PUT ANOTHER ONE IN BUT IT NEVER TURNED ON AND IT NEVER CONNECTED". PT IS IN THE ER NOW BECAUSE THEY FELL AT WORK AND NEEDS AN MRI AND IS REQUESTING WE FAX THE ER TO SHOW THEM WHAT THE PT HAS IMPLANTED. SINCE PT IS MOST LIKELY IN EOS STATE BY NOW, WARM TRANSFERRED PATIENT TO PRS SO THEY CAN HAVE AN IMPLANT SHEET FAXED OVER TO HCP.

  Patient problems: Pain

  MAUDE report 24471939 ↗
• MalfunctionFeb 25, 2026Intermittent Continuity; Failure to Deliver Energy

  ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT. WHEN ASKED WHAT THE CAUSE WAS OF THEIR STIMULATION TURNING ON AND OFF ON ITS OWN, THEY STATED THAT THEY WERE NOT SURE. THEY STATED THAT THE STEPS THAT WERE TAKEN TO RESOLVE THE ISSUE WAS THAT THEIR DOCTOR'S OFFICE RESOLVED THE PROBLEM. THEY STATED THAT THEY JUST NEEDED A REFRESHER OF USE.

  Patient problems: Pain

  MAUDE report 24443352 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  NO NEW EVENT DESCRIPTION INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24420321 ↗
• InjuryFeb 23, 2026Battery Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT STATING THEY WERE NOT USING THE UNIT AT THE TIME, IT HAD BEEN TURNED OFF FOR PROBABLY 12-15 MONTHS. PATIENT DID NOT CHARGE IT LIKE THEY SHOULD HAVE. PATIENT REPORTS THE BATTERY BECAME DEPLETED ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24412912 ↗
• InjuryJan 21, 2026Failure to Interrogate; Energy Output Problem; Battery Problem; Charging Problem; Communication or Transmission Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT STATING THE DEVICE WAS INOPERATIVE FOR LAST 4 YEARS. IT DIDN'T PROVIDE PAIN RELIEF EVEN FROM DAY 1 AND THE BATTERY STARTED TO CAUSE PAIN ITSELF. THEY HAVE A REMOVAL SCHEDULED FOR (B)(6) 2026.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 24135270 ↗
• MalfunctionJan 6, 2026Energy Output Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THERE WERE NO EXTERNAL/PATIENT FACTORS. THE CAUSE WAS DETERMINED TO BE THAT THE PATIENT WAS CONFUSED, AND MISTAKING THE STIMULATION FOR AN ASPECT OF NEUROPATHY. HE STATES THAT IT FEELS ALMOST IDENTICAL TO THE MACHINE ITSELF WHEN TURNED ON. THE DEVICE WAS REPROGRAMMED AND IS NOW HELPING WITH RELIEF. THE ISSUE WAS RESOLVED.

  Patient problems: Pain

  MAUDE report 23975342 ↗
• MalfunctionJan 6, 2026High impedance

  IT WAS REPORTED THAT CONTACTS #12 AND #13 WERE GREATER THAN 10,000 OHMS. THE PATIENT WAS REPROGRAMMED FOR ADEQUATE COVERAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974505 ↗
• MalfunctionDec 16, 2025Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT HAD A BROKEN DESKTOP CHARGER CONNECTOR PIN. CALLER STATED THIS BEGAN JUST A COUPLE OF DAYS AGO THIS TIME. CALLER DID NOT HAVE SERIAL NUMBER. CALLER WILL OBTAIN SERIAL NUMBER THEN CALL BACK FOR REPLACEMENT. CALLER STATED THE PATIENT HAD NOT SEEN THEIR DOCTOR IN A WHILE. CALLER / PATIENT DAUGHTER CALLED BACK STATED THE PATIENT CANNOT FIND THE DESKTOP CHARGER(DTC) CORD SERIAL NUMBER AND PATIENT NEED TO CHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS) . AGENT REOPENED THE CASE TO ADD SERIAL AND SENT REQUEST TO THE REPAIR DEPT FOR DTC CORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815555 ↗
• MalfunctionDec 8, 2025Improper or Incorrect Procedure or Method; Battery Problem; Charging Problem; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Battery Problem; Charging Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS TO GET MRI INFORMATION. THE CALLER STATED THAT THE PATIENT STIMULATOR HAS NOT BEEN TURNED ON IN YEARS. THE CALLER DID NOT HAVE OTHER INFORMATION ABOUT THE STATUS OF THE INS. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. TECHNICAL SERVICES (TSS) REVIEWED MRI INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. PATIENT CALLED STATED THEY NEED AN MRI AND MRI FACILITY NEED TO CONFIRM THE INS IS OFF. PATIENT STATED THE INS HAS BEEN DEAD FOR YEARS, INS WILL NOT TAKE A CHARGE. AGENT REVIEWED DEVICE FUNCTION, MRI ELIGIBILITY FORM, REPS ROLE AND PROVIDED TS NUMBER FOR HCP OFFICE TO CALL IF NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23747612 ↗
• MalfunctionDec 5, 2025Battery Problem; Battery Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS TO GET MRI INFORMATION. THE CALLER INDICATED THAT THE PATIENT CLAIMED THAT THE INS IS AT END OF SERVICE AND NO LONGER WORKS. THE PATIENT CONTACTED A REP ABOUT THIS ISSUE. THE CALLER DID NOT HAVE OTHER DETAILS ABOUT THE STATUS OF THE INS. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. TECHNICAL SERVICES (TSS) REVIEWED MRI INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727345 ↗

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