RestoreADVANCED™ 37713Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 00613994842367), received between Nov 15, 2016 and Apr 2, 2025 — classified as 38 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (26 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 106 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). CALLER REPORTED HAVING SYMPTOMS /ADVERSE EVENTS POTENTIALLY RELATED TO THEIR IMPLANTED DEVICE. CALLER SAID THEY WERE IN THE HOSPITAL ALL LAST WEEK AND WHEN AGENT ASKED IF THIS WAS RELATED TO THE MANUFACTURER DEVICE CALLER STATED THEY ARE NOT SURE. CALLER SAID THAT ON THEIR RIGHT LEG (SAME SIDE AS INS) FROM THE BUTT CHEEK TO THE TOE IS NUMB AND THEY ARE FEELING PINS AND NEEDLES SENSATION. CALLER STATED IT IS PAINFUL TOO (BUT THEY ALWAYS HAVE SOME PAIN IN THE LEG). PATIENT SAID IT'S GETTING A LITTLE BETTER BUT THE PAIN WAS SO BAD IN THE HOSPITAL THAT THEY COULDN'T EVEN LIFT IT UP OR MOVE IT. CALLER SAID THEY THINK IT COULD BE SCAR TISSUE OR SOMETHING BECAUSE THEY NEVER GOT IT TAKEN CARE OF AND SOMETHING, MAYBE NERVES, COULD BE GROWING AROUND IT. AGENT REDIRECTED PATIENT TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Numbness; Pain; Paresthesia; Scar Tissue; Undesired Nerve Stimulation

  MAUDE report 21753652 ↗
• MalfunctionDec 11, 2024Failure to Interrogate; Overheating of Device; Battery Problem; Charging Problem; Communication or Transmission Problem; Insufficient Device Problem Information; Failure to Interrogate; Overheating of Device; Battery Problem; Charging Problem; Communication or Transmission Problem; Insufficient Device Problem Information

  THE PATIENT REPORTED THAT THEIR IMPLANTED NEUROSTIMULATOR (INS) WAS NO LONGER WORKING. THEY EXPLAINED THAT 2 YEARS AGO (2019) THEY HAD TRIED CONNECTING WITH THE INS TO CHARGE IT, BUT IT WOULDN'T REGISTER AND THEY WERE GETTING AN ERROR MESSAGE. THEY COULD NOT RECALL WHAT THE ERROR MESSAGE WAS. DUE TO NOT BEING ABLE TO CONNECT TO CHARGE THE INS, THEY DECIDED TO STOP USING AND CHARGING THE INS. THEY DIDN'T KNOW WHO TO CALL TO HELP THEM WITH THIS ISSUE AND THEY CONFIRMED THEY HADN'T MET WITH A REP OR THEIR DOCTOR FOR TROUBLESHOOTING YET. NO SYMPTOMS REPORTED. THEY STATED THEIR CURRENT PAIN MANAGEMENT DOCTOR WAS WORKING WITH THEM TO HELP THEM FIND A DOCTOR WHO WILL TAKE THEIR INSURANCE AND PUT IN A NEW DEVICE. THE PATIENT WAS PROVIDED THE PHONE NUMBER FOR THE DOCTOR TO CALL TO SCHEDULE AN APPOINTMENT WITH A MANUFACTURER REPRESENTATIVE (REP) TO HAVE THE DEVICE CHECKED AND TO SEE IF THEY CAN GET IT WORKING AGAIN. THE PATIENT STATED THEY WOULD ASK THEIR CURRENT DOCTOR TO SCHEDULE AN APPOINTMENT WITH A REP. INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT REPORTED THEIR IMPLANT WAS NON-FUNCTIONAL FOR SEVERAL YEARS AND THE ISSU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20902866 ↗
• MalfunctionAug 15, 2024Electromagnetic Compatibility Problem; Insufficient Device Problem Information; Electromagnetic Compatibility Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. PATIENT STATED IF THEY GET SHOCK WITH 110 OR 220 VOLTS THE DEVICE TURNS OFF WITH THEIR IMPLANTS. FOR BEING SHOCK BY 110 AMP THEY WOULD USE REMOTE TO TURN BACK ON BUT WITH 220 AMP THEY WOULD CHARGE DEVICE TO FULL BEFORE ABLE TO TURN BACK ON. PT CONFIRMED THE ISSUE HAS BEEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990453 ↗
• MalfunctionMay 24, 2024Charging Problem; Charging Problem

  INFORMATION WAS RECEIVED FROM A PATIENT'S (PT) REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS CALLER STATED THAT THE PATIENT HAS NOT BEEN ABLE TO CHARGE THE IMPLANT FOR "YEARS" - LATER MENTIONED BEING "A COUPLE YEARS". PATIENT SERVICE SPECIALIST REVIEWED POSSIBLE OVER DISCHARGE AND REDIRECTED TO HEALTHCARE PROVIDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392288 ↗
• MalfunctionFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICES WERE SENT IN FOR DONATION, AND AN IN HOUSE FAILURE WAS FOUND. A BENT DESKTOP CHARGER CONNECTOR PIN WAS FOUND DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685107 ↗
• MalfunctionFeb 5, 2024Failure to Power Up; Battery Problem; Charging Problem; Insufficient Device Problem Information; Failure to Power Up; Battery Problem; Charging Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS PT MENTIONED THEIR IMPLANTED NEUROSTIMULATOR(INS) HAD COMPLETELY DISCHARGED BECAUSE THEY COULD NOT CHARGE THEIR INS BECAUSE THEIR RECHARGER SCREEN WOULD NOT ILLUMINATE SINCE FRIDAY. PT ATTEMPTED TO PLUG IN THE RECHARGER TO THE POWER SUPPLY FOR THE WHOLE DAY, BUT RECHARGER SCREEN WOULD NOT ILLUMIN ATE. PT THEN ATTEMPTED TO RECHARGE THE RECHARGER WITH ANOTHER AC POWER SUPPLY, BUT SCREEN STILL WOULD NOT ILLUMINATE AND THE DTC DID NOT APPEAR TO BE WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641580 ↗
• MalfunctionFeb 1, 2024Display or Visual Feedback Problem; Charging Problem; Display or Visual Feedback Problem; Charging Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. PT REPORTED RECHARGER (INSR) SCREEN WAS BLANK AND IT WON'T TAKE A CHARGE WHEN PT PLUGGED IT IN THE WALL. THE POWER SUPPLY (DTC) HAD THE GREEN LIGHT. PT DID NOT NOTICE ANY DAMAGE ON DTC OR INSR. NO SYMPTOMS WERE REPORTED. THEY LATER CALLED BACK AND CONFIRMED THE REPLACEMENT EQUIPMENT WAS WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623523 ↗
• MalfunctionFeb 1, 2024Charging Problem; Charging Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PT'S RECHARGER WAS NOT RECHARGING WITH THE DESKTOP CHARGER (DTC) PLUGGED IN FOR ABOUT A MONTH OR SO. PT MENTIONED THEY "JIGGLED" THE DTC, AND RECHARGER WILL FLASH AND STARTED RECHARGING, BUT ONLY RECHARGED A SMALL AMOUNT BEFORE THE RECHARGER STOPPED RECHARGING. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623278 ↗
• MalfunctionJan 15, 2024Failure to Power Up; Charging Problem; Communication or Transmission Problem; Failure to Power Up; Charging Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS PT REPORTED THEIR RECHARGER WAS ACTING UP THE PAST MONTH. PT STATED THE ERI MESSAGE STARTED ABOUT A MONTH AGO AND THEY WEREN'T ABLE TO TURN ON THEIR RECHARGER TODAY. PT STATED THE RECHARGER HAD THE LIGHTNING BOLT SHOW ON THE RECHARGER BUT NOTHING ELSE WAS DISPLAYING. PT NOTED THEY HADN'T SEEN THE EOS MESSAGE DISPLAY. PT STATED SOMETIMES IT WOULD CHARGE AND SOMETIMES IT WOULDN'T CHARGE AND PT WOULD MOVE THE ANTENNA AROUND BUT IT WAS COMPLICATED TO CONNECT TO THEIR IMPLANT (INS). PT MENTIONED THEIR HCP DID THEIR LAST FEW SURGERIES AND THEY DIDN'T HAVE A PAIN MANAGEMENT DOCTOR. PS REVIEWED ERI AND EOS INFORMATION TO PT AND ADVISED PT CONTACT THEIR HCP. A REPLACEMENT RECHARGER (INSR) WAS SENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18514994 ↗
• MalfunctionNov 14, 2023Charging Problem; Connection Problem; Material Integrity Problem; Charging Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT'S RECHARGER WAS CHARGING THE IMPLANT IN THEIR BODY BUT IT WOULD NOT RECHARGE ITSELF. THEY HAD BEEN CHARGING THE RECHARGER FOR TWO DAYS AND NOTHING HAPPENED. THE CONNECTOR PIN WAS "ALWAYS" CROOKED AND HAD BEEN FOR AS LONG AS THEY COULD REMEMBER. THE WIRES THAT GO FROM THE DESKTOP CHARGER INTO THE RECHARGER WERE "ALL MESSED UP" (THE PLASTIC CAME OFF OF THEM) AND THEY HAD TO TAPE IT UP; WIRES WERE EXPOSED WHERE IT PLUGGED INTO THE RECHARGER. THE ISSUE WAS NOT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130240 ↗
• MalfunctionNov 8, 2023Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. THE PATIENT REPORTED THE METAL PIECE SEEM LOOSE AND FELL OUT DESKTOP CHARGER (DTC) CORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097487 ↗
• MalfunctionNov 8, 2023Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT'S DESKTOP CHARGER WIRES WERE EXPOSED AND THE CONNECTOR PIN WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092696 ↗
• MalfunctionNov 7, 2023Charging Problem; Connection Problem; Material Integrity Problem; Charging Problem; Connection Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. THE CALLER HAD A BROKEN DESKTOP CHARGER (DTC) CONNECTOR PIN. PT SAYS THE DTC PIN IS WIGGLY AND WONT CHARGE THE RECHARGER (INSR). THEY SAID THIS WAS FIRST NOTICED THIS MORNING. AN EMAIL WAS SENT TO REPAIR TO REPLACE THE DESKTOP CHARGER. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085908 ↗
• MalfunctionNov 7, 2023Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DESKTOP CHARGER CONNECTOR PIN WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084320 ↗
• InjuryMay 19, 2023Delayed Charge Time; Delayed Charge Time

  INFORMATION WAS RECEIVED FROM A PATIENT (PT), REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL, WAS PT MENTIONED THEY HAD THEIR PREVIOUS INS REPLACED IN 2017. BECAUSE IN 2016 (ABOUT A YEAR BEFORE REPLACEMENT SURGERY) THEY NOTICED, THE INS TOOK LONGER AND LONGER TO CHARGE.  " (B)(4)" FOR A SIMILAR EVENT HAPPENING TO THEIR CURRENT IMPLANT. AND WANTING TO MEET WITH A REPRESENTATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962142 ↗
• MalfunctionApr 13, 2023Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS CALLER STATED THAT THEY HAVEN'T USED THEIR IMPLANT FOR AT LEAST 4 YEARS MAYBE LONGER BECAUSE THEY DIDN'T NEED IT ANYMORE. CALLER NOTED THAT IT KIND OF HURTS THEM SOMETIMES, SO THEY WANT TO HAVE IT TAKEN OUT. CALLER STATED OFF AND ON THEY'LL FEEL AN UNCOMFORTABLE SENSATION BETWEEN THEIR SHOULDER BLADES WHERE THE PADDLE LEAD IS. CALLER STATED IT'S HARD TO EXPLAIN BUT ISN'T A SEVERE PAIN. CALLER STATED IT WILL LAST FOR 2-3 DAYS THEN GO AWAY. CALLER ADDED THAT THE BATTERY BELOW THEIR HIP SEEMS LIKE IT WORKED IT'S WAY CLOSER TO THE SURFACE, AND THEY CAN SEE THE INDENTATION ON THEIR SKIN. CALLER ADDED IF THEY MOVE WRONG THEY GET A SHARP PAIN AT THAT SITE AS WELL EVERY ONCE IN A WHILE. CALLER NOTED A WHILE BACK THEY GOT A REFERRAL TO A CLOSER DOCTOR, BUT THEY DIDN'T WANT TO OPERATE SINCE THEY WEREN'T THE IMPLANTING DOCTOR. CALLER STATED THE IMPLANTING DOCTOR IS 4 HOURS AWAY. CALLER MENTIONED THEIR DOCTOR WANTS TO DO AN MRI OF THEIR HEAD. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Discomfort; Pain

  MAUDE report 16736596 ↗
• InjuryNov 11, 2022Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR LEG/BACK AND SPINAL PAIN INDICATIONS. THE REASON FOR CALL WAS 6 OR 7 YEARS AGO THE PTS INS WAS ACTING UP AND NOT HOLDING A CHARGE. PT HAD TO GET A NEW INS PUT IN BECAUSE IT WAS THERE FOR SO LONG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15780276 ↗
• InjuryNov 8, 2022Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  ON (B)(6) 2022, INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FAILED BACK SURGERY SYNDROME AND SPINAL PAIN INDICATIONS. THE PATIENT (PT) SAYS THEIR BATTERY HAS NOT BEEN WORKING FOR A FEW MONTHS NOW AND SAYS "THEY DID XRAYS AND I WANT TO KNOW IF YOU GOT THEM, WE HAVEN'T HEARD BACK FROM YOU". AGENT TOLD PT THAT PATS DOESN'T RECEIVE XRAYS, AND AGENT ASKED IF THE REASON THE INS ISN'T WORKING IS BECAUSE OF EOS OR ERI STATE AND PT BECAME COMBATIVE AND SAID "IT WAS SUPPOSED TO BE A FIVE YEAR BATTERY BUT IT LASTED LONGER". AGENT REVIEWED THE INS IS A 9 YEAR BATTERY LIFE, AND COULD BE IN EITHER EOS OR ERI STATE. PT GOT UPSET AND COULDN'T CONFIRM IF THEY EVER SAW EITHER OF THESE MESSAGES. PT SAYS THEY WANT TO GET INS REPLACED. PT SAYS THEY SEE A "DR THAN LEE AT PAIN MANAGEMENT". PT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. ON 2022-10-14, ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT REPORTING THAT THE PATIENT CLARIFIED THAT THEY DID RECEIVE A MESSAGE SAYING EOS OR ERI ON THEIR CONTROLLER AND THEY SCREENSHOTTED THE MANUFACTURER COMPANY. THEY STATED THAT THEY WERE REFERRED BY THE MANUFACTURER TO RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756940 ↗
• InjuryNov 3, 2022Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN AND OTHER CHRONIC/INTRACT PAIN (TRUNK/LIMBS). THE REASON FOR CALL WAS PT STATED THEY HAVE A NEUROSTIMULATOR, LABELED 'MY STIM' ON IT FROM THEIR PREVIOUS SPINAL CORD STIMULATOR. PT STATED THEY HAD THIS EXPLANTED BECAUSE 'IT DIDN'T WORK, I HAVE AN OLD ONE IN MY RIGHT SIDE." PT DISCONNECTED THE CALL, AND THEREFORE, FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. NO SYMPTOMS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721524 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD DISCOMFORT, SORENESS AND PINCHING. PATIENT HAD A LEAD REVISION. SHE IS DOING VERY WELL. PATIENT IS NOT GETTING ANY MORE RIB STIMULATION.

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

  MAUDE report 15058008 ↗
• InjuryJun 6, 2022Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR COMPLEX REG PAIN SYNDROME TYPE I AND SPINAL PAIN. THE REASON FOR CALL WAS TO GET MRI INFORMATION. THE CALLER INDICATED THAT THE IMPLANTED BATTERY IS DEAD AND THE PATIENT LOST REMOTE. WHEN ASKED FOR ADDITIONAL DETAILS THE CALLER PROVIDED THE FOLLOWING INFORMATION, WHEN THE PATIENT WAS IMPLANTED THEY HAD ISSUES WITH THE IMPLANTED DEVICE AND IT WAS HURTING HIS CHEST. ANOTHER NEUROSURGEON TOLD THE PATIENT NOT TO USE THE DEVICE. TROUBLESHOOTING WAS NOT REQUIRED. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT. THE REASON FOR CALL WAS PT MENTIONED THEIR "STIMULATOR BATTERY WAS NOT WORKING" SINCE 3 YEARS AGO. PT SAID THE SPINAL CORD STIMULATOR(SCS) HAS NOT WORKED FOR SOME TIME AND THEY WANTED TO GET THE SCS REMOVED BECAUSE THEY HAD PROBLEMS RELATED TO THE SCS IN THE PAST. PT SAID THEY HAD A HARD TIME FINDING AN HCP WHO WOULD REMOVE SCS, BUT THE PT EVENTUALLY FOUND DR. (B)(6), WHO TALKED TO THE PT AND SAID THE SCS WOULD BE DIFFICULT TO REMOVE COMPLETELY AND WOULD CAUSE PROBLEMS, BUT DISCUSSED THE POSSIBILITY OF REPLACING THE SCS WITH ANOTHER NEWER MODEL.

  Patient problems: Pain

  MAUDE report 14601659 ↗
• InjuryMay 25, 2022Improper or Incorrect Procedure or Method; Battery Problem; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Battery Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. THE REASON FOR CALL WAS THE PT REPORTED WHEN TRYING TO RECHARGE THEIR INS TODAY THE SCREEN WOULD BLINK A COUPLE OF TIMES AND THEN THE REPOSITION ANTENNA SCREEN WOULD DISPLAY. PATIENT SERVICES (PSS) HAD PATIENT TRY REPOSITIONING THE ANTENNA. PT SAID THEY HAVE NOT NEEDED THEIR THERAPY AS MUCH SO ITS BEEN A COUPLE OF MONTHS SINCE CHARGING THE INS. THE CALLER WAS REDIRECTED TO CONTACT THEIR MDT REPRESENTATIVE (REP). NO SYMPTOMS WERE REPORTED. IT WAS REPORTED THE REP INQUIRED ABOUT CHARGING POTENTIALLY OVERDISCHARGED INS. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE CAUSE OF THE POSSIBLE OVERDISCHARGE/EOS WAS UNDETERMINED. THE PATIENT WANTS THE INS REPLACED, IT HAS BEEN SCHEDULED FOR (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14502388 ↗
• MalfunctionMay 16, 2022Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN INDICATIONS. CALLER STATED THE INS HAS BEEN OFF FOR 8YRS. PS REVIEWED INFORMATION AND FOR HCP OFFICE TO CALL IF THEY HAVE QUESTIONS. THE INS FAILED 6 MONTHS AFTER IT WAS IMPLANTED, THE ANCHOR POINT FAIL MOVED AROUND IN THE BACK AND CAUSED EXTREME AMOUNT OF PAIN FOR A LONG TIME. CALLER STATED PATIENT HAS BEEN TRYING TO GET THE INS TAKEN OUT. THE INS WAS THRU WORK MANS - COMP AND THE CASE CLOSED AND THEY MOVED TO A DIFFERENT STATED, THEY NEED TO LOCATE A NEW HCP, AND DUE TO COVID EVERYTHING WAS PUSHED BACK AND NOW THEY HAVE TO FIND A NEW HCP. CALLER STATED THEY HAVE A HCP BUT THEY ARE NOT SURE THEY WILL BE SEEING HER AGAIN.

  Patient problems: Pain

  MAUDE report 14406224 ↗
• InjuryApr 29, 2022Overheating of Device; Overheating of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THEY HAD THEIR FIRST INS REPLACED DUE TO NORMAL BATTERY DEPLETION, BUT THEY HAD THEIR SECOND INS REPLACED BECAUSE THE INS WAS GETTING TO HOT WHEN CHARGING THE INS "INSIDE AND OUT." PT NOTED THEY WOULD SEE A TEMPERATURE SYMBOL ON THEIR RECHARGER SCREEN, BUT PT DID NOT KNOW WHEN THEIR INS WAS FEELING HOT OR WHEN THE MESSAGE APPEARED. PT NOTIFIED MEDTRONIC (MDT) ABOUT THE ISSUES, BUT WAS UNSURE WHEN THEY NOTIFIED THE REP. PT SAID THEY HAD THEIR INS REPLACED RIGHT AWAY AFTER THEY NOTIFIED THEIR MDT REP. SEE CASE #(B)(4) FOR THEIR 3RD INS BEING REPLACED. PT NOTED THEY WERE OUT OF NETWORK WITH THEIR HEALTHCARE PROVIDER (HCP). PATIENT SERVICES SPECIALIST (PSS) DOCUMENTING REPORTED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14251568 ↗
• InjuryDec 16, 2021Break; 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 REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR RSD/CAUSALGIA-COMPLEX REGIONAL PAIN SYN. IT WAS REPORTED THAT THE  PATIENT CAME IN FOR A REVISION AND THE EXTENSION WIRES WERE SEVERED. SHE ALSO COMPLAINED OF PAIN AT THE BATTERY SITE. THE PATIENT HAD MOVED TO FROM (B)(6) SO TIMELINES ON HOW LONG THE COMPLAINTS HAVE BEEN GOING ON ARE UNCLEAR. IMPEDANCES WERE ALL HIGH WHEN INS WAS INTERROGATED. PATIENT WAS VISIBLY UNCOMFORTABLE WHILE THE BATTERY WAS PAIRED TO TABLET. THE ENTIRE SYSTEM WAS EXPLAINED AND A NEW PADDLE LEAD AND INS WERE IMPLANTED. ISSUE RESOLVED.

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

  MAUDE report 13018660 ↗

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