Intellis™ 97716 (UDI 00643169781740)Recalls & reported problems

Summary

The FDA's MAUDE database contains 635 adverse event reports that list this exact device (DI 00643169781740), received between Mar 27, 2019 and Sep 25, 2026 — classified as 191 injuries, 444 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (178 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 635 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Failure to Deliver Energy

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was patient reported that since they had the implant put it the therapy "never worked", the stimulation "doesn't reach the area that it needed to hit". Pt mentioned they stop using since then, but now needed an MRI and they were trying to charge the implant but unable to charge it. Controller did not power on when the controller was removed from a/c cord. Pt asked for a manufacturer representative (rep) to help them with the device and the settings. Agent offered troubleshooting the device, tried to explain passive recharge mode to pt. Pt preferred an actual assistance of a Rep and stated they're "not savvy with technology and stuff". Agent reviewed HCP and Rep roles and redirected pt to healthcare provider(HCP) in reaching out to the Rep. Pt called back stating that they had called earlier as the INS never worked and the stimulation never hit the spot that the therapy was supposed to for their pain. Pt stated that the external equipment hadn't been used for a long time and they now need a MRI, so they need to charge their INS. Pt said that they were calling to coordinat

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50896734 ↗
• InjurySep 23, 2026Insufficient Device Problem Information

  Information was received from a healthcare professional (HCP) regarding an implantable neurostimulator. The reason for call was caller stated that the patient's (pt) stimulator has not been on and/or functional for 2 years. The caller stated the pt was now working with an HCP who intended to remove the device but was seeking an MRI first.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868874 ↗
• InjurySep 16, 2026Migration or Expulsion of Device; Malposition of Device; Insufficient Device Problem Information

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The pt reported that they had their INS removed and still had the external devices. Pt asked what they could do with the external devices left. Agent reviewed the donation/disposal process. Pt did not have the external devices during the call.  Agent asked why the INS was removed, and pt said they had the INS for 6 years, 3 of those years the stimulator was not working properly. Pt stated the leads fell off, the INS was protruding through the skin, and they were in excruciating pain. Pt mentioned getting injections for their pain.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 50792295 ↗
• InjuryJul 9, 2026Overheating of Device; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT'S INS WAS REMOVED IN 2024 AS IT "MALFUNCTIONED AND BURNED."

  Patient problems: Burn(s)

  MAUDE report 25763680 ↗
• MalfunctionJul 1, 2026Battery Problem

  INFORMATION WAS RECEIVED FROM PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR THE CALL WAS THAT THE PATIENT R EPORTED MEETING WITH THEIR MANUFACTURER REPRESENTATIVE (REP) TO MAKE ADJUSTMENTS BECAUSE THEIR INS BATTERY WAS DEPLETING FASTER THAN BEFORE. THE PATIENT STATED THAT THE REP OPTIMIZED THE INTENSITY AND LOWERED THE SETTINGS. THE PATIENT WILL CONTINUE TO MONITOR THE ISSUE AND WILL CONSULT THEIR HEALTHCARE PROVIDER (HCP) IF FURTHER ASSISTANCE IS NEEDED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679386 ↗
• MalfunctionJun 30, 2026Battery Problem; Charging Problem

  IT WAS REPORTED THAT WHEN CHARGING THE IMPLANTABLE NEUROSTIMULATOR (INS), IT DOES NOT STAY CHARGED FOR VERY LONG. PREVIOUSLY, THE INS BATTERY WOULD HOLD A CHARGE FOR ABOUT A WEEK, BUT NOW IT ONLY LASTS 1 TO 2 DAYS BEFORE THE BATTERY DRAINS. THE PATIENT COULD NOT RECALL THE EXACT DATE THE ISSUE STARTED, AS THE PATIENT MENTIONED THEY COULD SOMETIMES LOSE TRACK OF CHARGING EVENTS AND TIMELINES. THE PATIENT REPORTED FREQUENTLY CHARGING THE INS. THE AGENT HAD THE PATIENT PERFORM A RESET ON THE CONTROLLER BY REMOVING AND REINSERTING THE BATTERY. THE PATIENT CONFIRMED WITH THE AGENT THAT THERE WAS NO VISIBLE DAMAGE TO THE RECHARGER CORD, RECHARGER PINS, OR CONTROLLER PINS. THE PATIENT CLEANED THE CONNECTIONS BY WIPING THE RECHARGER PINS AND BLOWING AIR INTO THE CONTROLLER PORT. THE PATIENT THEN CONNECTED THE RECHARGER TELEMETRY MODULE (RTM) AND ATTEMPTED TO RECHARGE THE INS. THE PATIENT CONFIRMED THE CONTROLLER BATTERY LEVEL WAS AT 80% AND THE INS BATTERY WAS EMPTY, WITH AN EXCELLENT CONNECTION, PATIENT REPORTED THAT THEY CHARGED THE INS A FEW DAYS AGO. THE AGENT REVIEWED THE CONTROLLER LIGHT INDICATORS. AFTER A FEW MINUTES OF CHARGING, THE PATIENT REPORTED SEEING ONLY A RED TRIANGLE INDI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664108 ↗
• MalfunctionJun 10, 2026Failure to Deliver Energy; Electromagnetic Compatibility Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT STATES THEY HAD HIP SURGERY ABOUT A MONTH AGO AND SINCE THEN THEY HAVE NOT BEEN ABLE TO FEEL STIMULATION IN THEIR LEGS. PATIENT STATES THEY TRIED RESETTING THE CONTROLLER AND NOW THEY CAN GET A LITTLE BIT OF STIMULATION ON THE LEFT SIDE OF THEIR LEG BUT NOT THE RIGHT SIDE. THE PATIENT REPORTED TO AGENT THAT THEY TRIED TAKING THE BATTERY OUT AND PLACING IT BACK IN AGAIN, CHANGING THE SETTINGS AND STILL CANNOT FEEL STIMULATION ON THE RIGHT SIDE. AGENT PROVIDED NUMBER FOR NAS AND REDIRECTED TO THE HEALTHCARE PROVIDER (HCP).

  Patient problems: Insufficient Information

  MAUDE report 25459957 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTS DIFFICULTY WALKING DUE TO INCREASED HIP PAIN. PAIN SUBSIDED BY TURNING OFF SCS. PATIENT HAS NOW TURNED SCS OFF. ON (B)(6) 2025: PATIENT TURNED SCS BACK ON. DID NOT PROVIDE RELIEF. ON (B)(6) 2025: REPORTS HAVING TO TURN OFF SCS 2 WEEKS AGO DUE TO INCREASED PAIN WITH SCS ON (B)(6) 2025: MET WITH A REP FOR REPROGRAMMING. NOTES NO IMPROVEMENT AND STILL CAUSING HIP PAIN. ADDITIONAL INFORMATION INDICATED THAT THERAPY RESUMED ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT REPORTS DIFFICULTY WALKING DUE TO INCREASED HIP PAIN. PAIN SUBSIDED BY TURNING OFF SCS. PATIENT HAS NOW TURNED SCS OFF. ON (B)(6) 2025, MET WITH A REPRESENTATIVE FOR REPROGRAMMING. NOTES NO IMPROVEMENT AND STILL CAUSING HIP PAIN. ON (B)(6) 2026, SYSTEM EXPLANTED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 25161015 ↗
• MalfunctionMay 13, 2026Overheating of Device; Charging Problem; Connection Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS PATIENT REPORTED THEY WERE HAVING ISSUES CHARGING THEIR IMPLANT AND THE ISSUE BEGAN OFF AND ON FOR ABOUT A YEAR. PATIENT STATED THE RECHARGER CABLE HAD A SHORT IN IT AND THE CORD WAS GETTING HOT AND THE CONTROLLER PORT WAS BROKEN UP. A REQUEST WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE CONTROLLER AND RECHARGER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157525 ↗
• MalfunctionMay 11, 2026High impedance

  IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR WAS ASSOCIATED WITH HIGH IMPEDANCE, WITH IMPEDANCE VALUES REPORTED AS 40000 ON CONTACTS 0, 2, 3, AND 4. THE ISSUE WAS ONGOING AND NOT RESOLVED AT THE TIME OF THE REPORT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. 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 25138038 ↗
• MalfunctionMay 5, 2026Failure to Deliver Energy; Therapeutic or Diagnostic Output Failure

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS THE PATIENT REPORTED THAT ABOUT A WEEK AGO THEY SAW A MESSAGE ON THEIR CONTROLLER THAT SAID NONE OF THE SETTINGS CAN PROVIDE STIMULATION. THE PATIENT STATED THAT THEY CHARGED THE IMPLANT THIS MORNING AND THE CONTROLLER WAS AT 100% AND THE IMPLANT WAS AT 90%. AGENT ASKED THE PATIENT WHEN THEY FIRST SAW THE MESSAGE AND THE PATIENT STATED THEY WERE ON GROUP C AND THE STIMULATION WAS ON, BUT THEY WERE NOT FEELING STIMULATION. PT TRIED GROUP B AND DID NOT FEEL STIM. AGENT HAD THE PATIENT SWITCH TO GROUP A AND THEY WERE ABLE TO FEEL THE STIMULATION SENSATION. AGENT HAD CALLER GO BACK TO A GROUP WHERE SHE DID NOT FEEL STIM AND TRY TO TURN STIM UP--UPON DOING SO, 'SETTINGS NOT AVAILABLE' WAS DISPLAYED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE CALLER WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. CALLER MENTIONED WHILE WORKING WITH THE CONTROLLER THAT IT WAS 'SLOW'.

  Patient problems: Insufficient Information

  MAUDE report 25086834 ↗
• MalfunctionMay 5, 2026Energy Output Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PT REPORTED DISCONTINUING USE OF THEIR INS FOR APPROXIMATELY 6 DAYS DUE TO OVERSTIMULATION. THEY DESCRIBED EXPERIENCING A VIBRATING SENSATION IN THE LOWER LEGS, WHICH THEY RECOGNIZE AS A SIGN OF OVERSTIMULATION. IN RESPONSE, THE PT PROGRESSIVELY DECREASED THE INTENSITY UNTIL ULTIMATELY TURNING THE DEVICE OFF. PT NOTED THAT ON SATURDAY THEY EXPERIENCED A SUDDEN RETURN OF PAIN, DESCRIBING THEIR NECK AS FEELING "TOTALLY FROZEN" AND NOTED THAT THE PAIN WAS EXCRUCIATING. PT MENTIONED THAT THEY CALLED THEIR PAIN CLINIC AND THEY WERE INSTRUCTED TO CALL THE MANUFACTURER FIRST TO SEE IF THIS CAN BE FIXED OVER THE PHONE. AGENT ASKED, PT STATED THEY HAD ALREADY ATTEMPTED TO CHANGE GROUPS AND ADJUST THEIR THERAPY SETTINGS. AGENT REVIEWED THE ROLE OF THE REP AND PT SERVICES. THE PT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. AGENT ALSO REVIEWED NAS NUMBER.

  Patient problems: Device Overstimulation of Tissue; Discomfort; Muscular Rigidity; Pain

  MAUDE report 25084905 ↗
• InjuryApr 28, 2026Delayed Charge Time; Battery Problem; Charging Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP) WHO REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED ON (B)(6) 2026. THEY REPORTED NO COMPLAINTS WERE KNOWN AT THE TIME OF THE REPLACEMENT AND THE BATTERY WAS TOO LOW TO BE INTERROGATED PRIOR TO THE PROCEDURE. THEY REPORTED THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25023585 ↗
• MalfunctionApr 16, 2026Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED CONCERN THAT THE IMPLANT MAY HAVE SHIFTED AND NOTED SWELLING AND TENDERNESS AT THE IMPLANT SITE ABOUT 2 DAYS AGO. PATIENT STATED THAT THEY DID NOT CURRENTLY HAVE INSURANCE COVERAGE AND EXPRESSED CONCERN ABOUT POTENTIAL COSTS IF THE PHYSICIAN RECOMMENDED IMPLANT BATTERY REPLACEMENT. PATIENT ALSO INQUIRED WHETHER MEDTRONIC WOULD COVER THE COST IF THE PHYSICIAN RECOMMENDED IMPLANT BATTERY REPLACEMENT. AGENT REDIRECTED PATIENT TO THEIR HEALTHCARE PROVIDER FOR EVALUATION.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24895786 ↗
• MalfunctionMar 31, 2026Failure to Deliver Energy; Failure to Interrogate; Communication or Transmission Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT REPORTING THAT THE CONTROLLER WILL SHUT OFF AND STOP STIMULATION FOR NO REASON, WHEN I GO TO TURN IT ON IT SHOWS ¿NO DEVICE FOUND¿. I THEN HAVE TO PRY OPEN THE BATTERY COVER WHICH IS VERY DIFFICULT SINCE MY DOMINANT HAND IS FUSED. I JUST BARELY LIFT THE BATTERY UP TO RESET THE CONTROLLER AND THEN IT WORKS. I HAVE BEEN CORRESPONDING WITH MY LOCAL REP AND ALSO MY DOCTOR AND THEY WANT TO REPLACE THE CONTROLLER ASAP AND SEE IF IT HAPPENS AGAIN. SHE WANTED TO MEET TODAY BUT MY HUSBAND HAS THE CAR FOR HIS TEST AND DR. APPOINTMENT SO I AM TRYING TO GET ANOTHER DAY THIS WEEK TO MEET WITH HER TO EXCHANGE THE CONTROLLER. AFTER MEETING WITH MY DR YESTERDAY IT WAS NOT DETERMINED WHY THE CONTROLLER WAS SHUTTING OFF. THIS DEFINITELY WILL BE DONE THIS WEEK ON REPLACING THE CONTROLLER. I HAVE BEEN HAVING ISSUES WHEN I GO TO RECHARGE MY BATTERY THAT THE CONTROLLER CAN¿T FIND A DEVICE AND I ALSO HAVE TO OPEN THE BATTERY COMPARTMENT TO RESET THE CONTROLLER, THEN IT WORKS.

  Patient problems: Insufficient Information

  MAUDE report 24743512 ↗
• InjuryMar 19, 2026Migration or Expulsion of Device; Unintended Collision; Therapy Delivered to Incorrect Body Area

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). REP REPORTS THAT THE PATIENT WAS IN A CAR ACCIDENT "MONTHS AGO", EXACT DATE UNKNOWN. REP REPORTS THAT AFTER THIS CAR ACCIDENT THE PATIENT TURNED STIMULATION ON AND WAS FEELING STIMULATION IN THE WRONG LOCATION, WHICH LED TO THE PHYSICIAN TAKING AN X-RAY AND DISCOVERING THE LEADS HAD MIGRATED "ALL THE WAY UP TO T4".  REP REPORTS THE SYSTEM WAS REPLACED, DEVICES WERE DISCARDED BY THE CUSTOMER. REP SPOKE WITH PATIENT YESTERDAY AND THE ISSUE WAS RESOLVED.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 24644144 ↗
• MalfunctionMar 10, 2026Break; High impedance; Therapeutic or Diagnostic Output Failure

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT SAID THEY ARE SEEING SETTINGS NOT AVAILABLE ON THEIR CONTROLLER. THEY GO TO DIFFERENT LEVELS AND THIS DOES NOT FIX THE ISSUE. PATIENT SAID THEY HAVE TRIED RESETTING THE CONTROLLER. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. PT WAS ASKED WHAT THE CAUSE WAS FOR THEIR SETTINGS NOT AVAILABLE MESSAGE. PT RESPONDED THAT SOME OF THE LEADS WERE BROKE/MESSED UP AND SO THE REP HAD TO REROUTE THEIR USAGE TO OTHER LEADS. PT WAS TOLD THEY WILL MONITOR THIS. PT STATED THE ISSUE HAS BEEN RESOLVED FOR NOW. KEEPING AN EYE AND HOPING NO OTHER ONES BREAK. USING SURGERY AS A LAST OPTION TO REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563090 ↗
• MalfunctionMar 9, 2026Overheating of Device; Communication or Transmission Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. PT REPORTED THAT THEIR BACK HAD GOTTEN SO MUCH WORSE. THEY COULD NOT SIT THERE AND CHARGE THE IMPLANT LIKE IT SAID. PT STATED THAT THEY DIDN¿T KNOW IF IT WAS JUST BECAUSE THEY HURT SO BAD SITTING THERE OR IF THE ISSUE WAS WITH THE EQUIPMENT NOT WORKING GOOD. PT NOTED THAT THE RECHARGER WOULD GET WARM WHEN THEY WERE SITTING ON IT AND THEY WOULD HAVE TO TAKE IT OFF. PT ALSO STATED THAT IT TOOK SO LONG FOR THEM TO TRY TO MAKE CONNECTIONS. WHEN ASKED FOR THE EVENT DATE, THE PT MENTIONED THAT THEY HAD MOVED FROM ONE TOWN TO ANOTHER AND THE EQUIPMENT GOT MISPLACED FOR QUITE A WHILE IN THE LAST 3 MONTHS. AGENT ASKED AND PT DID NOT HAVE THEIR EQUIPMENT AT THE TIME OF THE CALL. PT INQUIRED ABOUT HOW LONG THE IMPLANT LASTS FOR AND THE AGENT REVIEWED THE LONGEVITY OF THE IMPLANT. AGENT ADVISED PT TO CALL BACK WHEN THEY HAVE THEIR EQUIPMENT FOR FURTHER TROUBLESHOOTING. SEE GENERAL TEXT FOR OMITTED INFORMATION.

  Patient problems: Burning Sensation; Insufficient Information; Pain

  MAUDE report 24549524 ↗
• MalfunctionMar 6, 2026Failure to Deliver Energy; Charging Problem; Loss of Data

  INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE (PT REP) REGARDING EXTERNAL DEVICE. THE REASON FOR CALL WAS PATIENT REP STATED THAT THE CONTROLLER IS OFF AND THEY CAN'T GET IT ON AND PATIENT REP STATED THE ISSUE STARTED WAY FOUR MONTHS AGO. AGENT INSTRUCTED PATIENT REP TO CHECK FOR VISIBLE DAMAGE; PATIENT REP CONFIRMED NO VISIBLE DAMAGE TO THE RECHARGER, CONTROLLER COMPARTMENT PINS, CONTROLLER PORT AND LI BATTERY PACK PINS. AGENT HAD PATIENT REP RESET THE CONTROLLER WITH AC POWER SUPPLY; PATIENT REP CONFIRMED CONTROLLER POWERED ON AND A GREEN BLINKING LIGHT WAS ABOVE THE SCREEN. CONTROLLER SHOWED 50% RECHARGING AND IMPLANT 70%. PATIENT REP MENTIONED PATIENT LOST ALL OF THE PROGRAMMING. PATIENT REP PRESSED THE THERAPY BUTTON THEN MENTIONED THE CONTROLLER SHOWED NO DEVICE FOUND THEN CONNECT THE RECHARGER. AGENT INSTRUCTED PATIENT REP TO START A CHARGE SESSION; IMPLANT WAS RECHARGING WITH EXCELLENT QUALITY. AGENT WALKED PATIENT REP THROUGH TURNING THE STIMULATION ON AND PATIENT REP CONFIRMED THE STIMULATION WAS NOW ON. LATER, PT REP CALLED BACK STATING THE CONTROLLER KEPT ON SAYING STIMULATION OFF AND THEY CAN'T GET THE INS TO RECHARGE ENOUGH THAT THEY CAN USE THE STIMULATION

  Patient problems: Insufficient Information

  MAUDE report 24531888 ↗
• MalfunctionFeb 24, 2026Failure to Deliver Energy

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

  Patient problems: Insufficient Information

  MAUDE report 24430077 ↗
• MalfunctionFeb 10, 2026Failure to Interrogate; Charging Problem; Communication or Transmission Problem

  THE REASON FOR CALL WAS PATIENT (PT) REPORTED THAT IT'S BEEN 10 DAYS SINCE THEY COULDN'T CHARGE THE IMPLANT AND THEY KEPT GETTING NO DEVICE FOUND MESSAGE. THE NURSE (CALLER) TOOK OVER THE CALL TO HELP THE PATIENT. AGENT HAD CALLER RESET THE CONTROLLER, INSPECT VISIBLE DAMAGE TO THE BATTERY COMPARTMENT PINS, BATTERY PACK, RECHARGER AND CONTROLLER PORT, AND CLEAN THE CONNECTIONS. CALLER CONFIRMED NO VISIBLE DAMAGE. AGENT HAD CALLER START A RECHARGING SESSION, BUT CALLER GOT NO DEVICE FOUND MESSAGE AGAIN AND WENT TO PASSIVE RECHARGE MODE AFTER HITTING RECHARGE. AGENT REVIEWED PASSIVE RECHARGE, BUT THEY ONLY GOT 48 AFTER REPOSITIONING THE PADDLE OVER THE IMPLANT. WHEN ASKED, CALLER CONFIRMED PATIENT DIDN'T HAVE ANY RECENT FALLS OR TRAUMAS AND DIDN'T LOSE OR GAIN WEIGHT. CALLER STATED THEY WILL EXPLAIN ALL THE INFORMATION TO THE PATIENT, BUT CALLER ASKED WHO THEY COULD CONTACT IF THEY STILL COULDN'T GET PAST TO 49. AGENT REVIEWED THE ROLE OF REP, PROVIDED NAS PHONE NUMBER, AND REDIRECTED TO MANUFACTURING REPRESENTATIVE (REP) AND HEALTHCARE PROVIDER (HCP) TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305566 ↗
• MalfunctionFeb 9, 2026Intermittent Continuity; Failure to Deliver Energy

  ON 2026-FEB-05 (B)(6) (CON): INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED THAT THEY HAVE BEEN UNABLE TO FEEL ANY STIMULATION AND EXPERIENCING PAIN SINCE MONDAY OR TUESDAY OF HIS WEEK. PATIENT CONFIRMED THE STIMULATION IS ON. PATIENT STATED THAT WHEN THE IMPLANT BATTERY IS AT 100%, IT TYPICALLY LASTS FOR MORE THAN ONE WEEK. PATIENT CONFIRMED CONTROLLER BATTERY AT 50% AND IMPLANT BATTERY AT 60%. AGENT HAD THE PATIENT TO CHECK THE PROGRAMS THEY HAVE. PATIENT MENTIONED HAVING GROUP A AND B; CURRENT THERAPY GROUP IS SET TO GROUP B. AGENT WALKED THE PATIENT THROUGH ADJUSTING STIMULATION INTENSITY. PATIENT REPORTED INTENSITY WAS AT 1.0; PATIENT INCREASED THE INTENSITY TO 3.6 AND REPORTED FEELING STIMULATION IN BACK, LOWER BACK, HIPS, AND LEGS. PATIENT STATED THEY FELT BETTER AFTER ADJUSTMENT. PATIENT REPORTED STIMULATION INTENSITY RETURNED TO 1.0 AND CAN'T FEEL ANYTHING. PATIENT NOW REPORTS FEELING STIMULATION ONLY IN THE BACK. THE ISSUE WAS NOT RESOLVED. AGENT REDIRECTED THE PATIENT TO HCP FOR FURTHER ASSISTANCE.

  Patient problems: Pain

  MAUDE report 24292311 ↗
• MalfunctionJan 9, 2026Migration or Expulsion of Device

  LEAD MIGRATION/DISLODGEMENT WAS ALLEGED. IT WAS REPORTED THAT RECENT IMAGING SHOWED THE PATIENT'S LEADS MAY HAVE MOVED INTO INTERLAMINAR SPACE. THE PATIENT HAD INADEQUATE PAIN RELIEF. THE PATIENT DOES NOT WANT TO PROCEED WITH A LEAD REVISION AT THIS TIME.

  Patient problems: Pain

  MAUDE report 24023170 ↗
• MalfunctionJan 6, 2026Failure to Interrogate; Unintended Collision; Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Communication or Transmission Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  PATIENT FELL ON WHERE THEIR INS WAS IMPLANTED ON (B)(6) AND FEW DAYS AFTER THEIR BATTERY STARTED ACTING UP. SUDDEN JOLTS AND STRONG STIMULATION DURING SLEEP WERE EXPERIENCED BY THE PATIENT. PATIENT WENT ON A PLANE TRIP ON 23TH OF DECEMBER AND TURNED OFF THEIR STIMULATION BEFORE FLIGHT. PATIENT TURNED THEIR STIMULATION BACK ON AFTER AND THEY FELT STRONG STIMULATION IN THEIR RIBCAGE AND STOMACH AREA. PATIENT THEN NOTICED THEY WERE HAVING A LOT OF PAIN TODAY AND THEY GOT NO DEVICE FOUND. PATIENT HAD NOTICED THAT THEIR STIMULATION HAD BEEN POSITIONAL AND NOTICED STRONGER STIMULATION WHEN LAYING DOWN AND ZAPS IN CERTAIN POSITIONS. DURING CALL PATIENT DID A PASSIVE RECHARGE SESSION AND WAS ABLE TO CHARGE THEIR INS NORMALLY, INS CHARGE WAS ON 90%. PATIENT HAD NOTICED THAT THEIR DATE AND TIME WERE INCORRECT EARLIER TODAY BUT ON THE CALL DATE AND TIME WERE CORRECT. FOR THE UNEXPECTED STIMULATION, AGENT REDIRECTED PATIENT TO THEIR HCP. PATIENT MENTIONED HISTORICAL EVENTS WHERE THEY HAD NEVERO BATTERY REPLACED IN THE PAST AND SEVERAL OF THEIR STIMULATORS WERE REPLACED BECAUSE INS GOT TOO OLD AFTER 6 TO 10 YEARS.

  Patient problems: Electric Shock; Pain; Undesired Nerve Stimulation

  MAUDE report 23974546 ↗
• MalfunctionDec 29, 2025Battery Problem; Battery Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT. THE CIRCUMSTANCES THAT LED TO IMPLANT BATTERY DEPLETION WAS ABOUT THE RECHARGER WAS BAD. RECHARGER WAS REPLACED AND RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904373 ↗

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