RestoreULTRA™ 37712 (UDI 00613994842343)Recalls & reported problems

Summary

The FDA's MAUDE database contains 249 adverse event reports that list this exact device (DI 00613994842343), received between May 2, 2014 and Jun 25, 2025 — classified as 92 injuries, 157 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (73 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 249 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Battery Problem; Battery Problem

  THE REASON FOR CALL WAS CALLER RECEIVED A LETTER FROM DEVICE REGISTRATION AND STATED THEY SPOKE WITH PRS AND THE PRS AGENT SAID PATIENT SERVICES COULD GIVE INFO HOW TO GET THE DEVICE REACTIVATED BECAUSE IT HAD BEEN DEAD FOR 5 YEARS. PT SAID IT WAS AROUND 2018-2019. PT SAID THE BATTERY ONLY LASTED FOR ABOUT 6 YEARS. REDIRECTED TO HCP. PT DID NOT HAVE ANY MANAGING HCP. PT WAS NOT ABLE TO COMPLETE THE UPDATE ONLINE FOR THEIR ID CARD BECAUSE THEY DID NOT HAVE A MANAGING HCP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328852 ↗
• MalfunctionAug 5, 2024Insufficient 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 THE DEVICE HAS NEVER WORKED FOR YEARS. THEY NEED TO HAVE AN MRI OF THEIR CERVICAL NECK. PATIENT SERVICE SPECIALIST REVIEWED MRI INFORMATION WITH THE PATIENT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. AGENT ATTEMPTED TO CLARIFY IF THE PATIENT HAD NOTIFIED A MANUFACTURER REPRESENTATIVE ABOUT THE ISSUE, BUT THE PATIENT SEEMED CONFUSED AND DID NOT PROVIDE A CLEAR ANSWER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT (PT). THEY REPORTED THAT THEY HAD THE DEVICE PUT IN THEIR LOWER BACK ON THE RIGHT SIDE. PT NOTED IT DIDN'T WORK. THE DEVICE WAS PUT IN ON (B)(6) 2013. PT WENT TO SEE THEIR DOCTOR SEVERAL TIMES AND THEY WERE NEVER ABLE TO UNDERSTAND THE CAUSE OF THE ISSUE. PT TRIED TO HAVE THEIR DOCTOR REMOVE THE DEVICE, BUT THEY WOULD NOT DO IT BECAUSE OF THE PATIENT'S HEALTH. THE ISSUE HAS NOT BEEN RESOLVED AND THE PATIENT DID NOT TRY TO USE THEIR DEVICE BECAUSE OF THEIR HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19909057 ↗
• MalfunctionJun 26, 2024Battery Problem; Charging Problem; Battery Problem; Charging Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT REPORTED THAT THEIR IMPLANT BATTERY DID NOT LAST AS LONG AS THEY WERE TOLD IT WOULD LAST, IT DID NOT LAST 7 YEARS. PATIENT REPORTED THAT THEY WANT AND NEED TO GET A NEW IMPLANT BATTERY BUT THAT THEY CANNOT; PATIENT ADDED THAT THE MANUFACTURER CALLED THEM AND TOLD THEM ABOUT A NEW BATTERY AND THEY WERE INTERESTED. PATIENT MENTIONED THAT THEY WERE LOOKING FORWARD TO HAVING THE IMPLANT REPLACED, BUT THE MANUFACTURER WOULD ONLY ACCEPT SO MUCH FOR THE BATTERY. PATIENT ALSO MENTIONED THAT THE CENTER WOULD ONLY PAY SO MUCH AND THE MANUFACTURER WOULD NOT ACCEPT WHAT THE CENTER WANTED TO PAY FOR THE IMPLANT. PATIENT NOTED THAT THEY HAVE MEDICARE AND SO THEY CAN ONLY PAY AND DO SO MUCH FOR THE REPLACEMENT. PATIENT MENTIONED THAT MANUFACTURER WILL NOT MEET THE CENTER AT A REASONABLE PRICE FOR THE REPLACEMENT BATTERY AND THAT THE PATIENT IS VERY UPSET. PATIENT ALSO MENTIONED THAT THE NURSE AT THE CENTER HAS BEEN TRYING TO GET IN CONTACT WITH THE MANUFACTURER AND HAS BEEN HITTING A BRICK WALL. AGENT REVIEWED THAT THE SALES REPS ARE THE NEGOTIATORS WITH THE DOCTORS AND THAT THEY HAVE

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

  MAUDE report 19616629 ↗
• InjuryMay 21, 2024Migration or Expulsion of Device; Malposition of Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration or Expulsion of Device; Malposition of Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT (PT). THEY REPORTED THAT THE DEVICE WAS INSTALLED IN THEIR LEFT BUTTOCKS. PT REPORTED THE BATTERY DIED ON ITS OWN AND THE ISSUE HAS NOT BEEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19363526 ↗
• InjuryMay 13, 2024Adverse 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). THE REASON FOR CALL WAS PATIENT NOTED THEY HAD A NEURO STIMULATOR PUT IN 9 YEARS AGO AND IT WORKED FOR ABOUT A MONTH AND THEN THEIR BODY SHUT DOWN AND THEIR BODY REJECTED IT. PATIENT NOTED IT WAS A RECHARGEABLE AND THEY HAD TO RECHARGE IT THEN THEY WERE IMPLANTED WITH A NON RECHARGEABLE INS.

  Patient problems: Foreign Body Reaction

  MAUDE report 19305445 ↗
• MalfunctionMar 22, 2024Failure to Power Up; Failure to Power Up

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN, :CERVICAL/NECK. IT WAS REPORTED THAT  THE PROGRAMMER WON'T POWER ON. PT STATED THEY REPLACED THE BATTERIES AND IT STILL WON'T POWER ON. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE PROGRAMMER. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18962776 ↗
• InjuryMar 21, 2024Battery Problem; Battery Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THE CAUSE OF THE MULTIPLE DEVICES RUNNING OUT OF JUICE AND HAVING TO BE EXPLANTED WAS DUE TO BATTERY FAILURE. THEY USED THEM FASTER THAN ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951755 ↗
• InjuryMar 15, 2024Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). DOCTOR REPORTS PATIENT (PT) WANTS THE PERIPHERAL NERVE LEAD AND INS THAT IS AT EOS REMOVED BECAUSE IT IS "TOO BULKY AND UNCOMFORTABLE." THE PERIPHERAL NERVE LEAD IS PLACED ON THE MEDIAN NERVE. PROVIDED NUMBER TO DOCTOR TO DISCUSS EXPLANTING PERIPHERAL NERVE LEAD.

  Patient problems: Discomfort

  MAUDE report 18914927 ↗
• MalfunctionFeb 7, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN AND LUMBAR RADICULOPATHY. THE REASON FOR CALL WAS THAT WITH THE INS NOT EVEN BEING CHARGED, THE INS WAS SHOCKING THEM AND THAT IT WOULD HAPPEN RANDOMLY THROUGHOUT THE DAY. PT STATED THAT THE SHOCKING WOULD STAY FOR LIKE 5-10 SECONDS AND THEN THE SHOCKING WOULD GO AWAY. PT STATED THAT THEY DIDN'T FEEL THE SHOCKING WHEN THE INS WAS TURNED ON. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PT STATED THEY NEVER HAD AN ISSUE OR PROBLEM WITH THE INS. PT WAS GOING TO CALL THEIR REGULAR DOCTOR TO COORDINATE A MEETING WITH A MANUFACTURER REPRESENTATIVE (REP).

  Patient problems: Electric Shock

  MAUDE report 18664031 ↗
• MalfunctionFeb 2, 2024Failure to Power Up; Charging Problem; Connection Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Failure to Power Up; Charging Problem; Connection Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT'S (PT) EXTERNAL DEVICE. IT WAS REPORTED THAT THE PT STARTED TO GET A HEADACHE AS THEY HADN'T CHARGED THEIR DEVICE IN A WHILE. THE RECHARGER WAS PLUGGED IN TO CHARGE ALL NIGHT, BUT THE FOLLOWING DAY THE RECHARGER WOULD NOT TURN ON. IT WAS REPORTED THAT THE GREEN LIGHT WOULD COME ON AND STAY ON, BUT THE CONNECTOR PIN CAME OFF IN THE DESKTOP CHARGER. AN EMAIL WAS SENT TO REPAIR TO REPLACE THE DESKTOP CHARGER.

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

  MAUDE report 18632635 ↗
• MalfunctionJan 19, 2024Display or Visual Feedback Problem; Failure to Power Up; Battery Problem; Adverse Event Without Identified Device or Use Problem; Display or Visual Feedback Problem; Failure to Power Up; Battery Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REPRESENTATIVE (PT REP) REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS CALLER MENTIONED PT RECEIVED "CHARGE THE RECHARGER" SCREEN WHEN RECHARGER WAS ALREADY PLUGGED INTO POWER SUPPLY; RECHARGER THEN WENT BLANK/UNRESPONSIVE AND PT COULD NOT GET RECHARGER TO TURN BACK ON. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE DESKTOP CHARGER (DTC). NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18543298 ↗
• InjuryJan 12, 2024Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, CLINICAL (B)(4) (HCP, SDY): INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THEIR WAS LEAD MIGRATION; LEAD IS COILED. IT WAS REPORTED THEIR WAS DECREASED PAIN RELIEF. ON (B)(6) 2014, LEAD WAS SURGICALLY ASSESSED AND UNCOILED THEN RE-ANCHORED.

  Patient problems: Insufficient Information

  MAUDE report 18504317 ↗
• MalfunctionNov 29, 2023High impedance; Connection Problem; High impedance; Connection Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR LUMBAR RADICULOPATHY AND SPINAL PAIN INDICATIONS. IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY IN REMOVING LEAD FROM OLD BATTERY. UPON INSERTING LEAD INTO NEW BATTERY, HE RECEIVED RED CONNECTIVITY ON ELECTRODE 7 AND 15. HE TRIED REINSERTING LEAD AND CONNECTIONS ON 7 AND 15 REMAINED RED. WE WERE ABLE TO SUCCESSFULLY PROGRAM AROUND CONNECTIONS. REP REPORTED EFFECTIVE THERAPY WAS ACHIEVED. THE PATIENT WILL BE SEEN AGAIN AT HIS POST OP APPOINTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229100 ↗
• MalfunctionNov 22, 2023Failure to Interrogate; Overheating of Device; Communication or Transmission Problem; Insufficient Device Problem Information; Failure to Interrogate; Overheating of Device; Communication or Transmission 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 PT REPORTED THAT ABOUT 2 WEEKS AGO THEY NOTICED THE RECHARGER WAS BECOMING HOT AND STARTED MAKING LOUD CLICKING NOISES. PT STATED OVER THE PAST WEEKEND THEY WERE TRYING TO CHARGE THEIR INS AND "NO DEVICE FOUND" CONTINUED TO DISPLAY AND THEN SYSTEM PROBLEM RM03 DISPLAYED. PT COMMENTED THAT THEIR INS IS IMPLANTED IN THEIR CHEST AND IS USED TO TREAT MIGRAINES AND IF THEY ARE WITHOUT THERAPY, THEY GET MIGRAINES THAT WILL NOT GO AWAY. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193443 ↗
• MalfunctionNov 15, 2023Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE (PT REP.) REGARDING AN EXTERNAL DEVICE. PT REP. REPORTED THE DESKTOP CHARGER (DTC) CONNECTOR PIN BROKE SINCE WITHIN "THE PAST COUPLE WEEKS." PT REP. SAID THE PT WAS IN THE HOSPITAL AND CONFIRMED THE HOSPITAL VISIT WAS NOT RELATED TO COMPLICATIONS WITH THE SPINAL CORD STIMULATOR (SCS). PT REP ALSO REPORTED THAT THE PT HAD A FRAYED RECHARGER ANTENNA CORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140453 ↗
• MalfunctionNov 10, 2023Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THEY HAD A BROKEN DESKTOP CHARGER (DTC) CONNECTOR PIN. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18116090 ↗
• 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 AND NOW THE RECHARGER WILL NOT RECOGNIZE DTC PLUGGED INTO THE RECHARGER. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085414 ↗
• MalfunctionNov 7, 2023Connection Problem; Material Integrity 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, PATIENT SAID THE PIN BROKE ABOUT A WEEK AGO AND THEY COULD CHARGE THE RECHARGER IF THEY HELD THE PIN. NO SYMPTOMS OR PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085231 ↗
• InjuryOct 12, 2023Migration or Expulsion of Device; Insufficient Device Problem Information; Migration or Expulsion of Device; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT (PT). THE PT REPORTED THE CAUSE OF THE MIGRATION IS UNKNOWN. THE PT HOPES TO HAVE SURGERY TO REMOVE THE BATTERY. THE ISSUE HAS NOT YET BEEN RESOLVED, AS PT IS WAITING TO SEE IF THEIR DOCTOR WILL TAKE THEIR CASE. WEIGHT WAS ASKED, BUT NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17920855 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RESPONSE WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING PATIENT'S REMOVAL OF DEVICE AND STATING PATIENT HAS SEVERE STENOSIS UNDER HER PADDLE HENCE WHY WE ARE REMOVING IT.

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

  MAUDE report 17599740 ↗
• InjuryAug 2, 2023Charging Problem; Insufficient Device Problem Information; Charging Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. CALLER REPORTS PATIENT IS NEEDING A BATTERY REPLACEMENT AS IT IS DEAD AND NOT WORKING. CALLER DID NOT PROVIDE ANY ADDITIONAL INFORMATION AND DID NOT KNOW WHEN THE BATTERY DIED OR STOPPED WORKING, BUT BELIEVES IT WAS RECENTLY. CALLER DID NOT KNOW WHO THE PATIENT'S PHYSICIAN IS. TS TRANSFERRED CALLER TO NAS, AS CALLER REQUESTED A REP BE PRESENT FOR THE REPLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PT. IT WAS REPORTED THAT THE BATTERY STOPPED CHARGING. PATIENT IS HAVING SURGERY ON JUNE 29TH TO REPLACE THE BATTERY.

  Patient problems: Insufficient Information

  MAUDE report 17444496 ↗
• InjuryMay 16, 2023Charging Problem; Charging Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PT REP. MENTIONED THE PT HAD THEIR PREVIOUS INS EXPLANTED AND REPLACED BECAUSE THE INS WAS NOT CHARGING RIGHT AND THERE WAS A "BATTERY PROBLEM" IN 2018. PATIENT SERVICES SPECIALIST(PSS) DOCUMENTING REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940452 ↗
• MalfunctionApr 17, 2023Migration or Expulsion of Device; Delayed Charge Time; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Delayed Charge Time; Adverse Event Without Identified Device or Use Problem

  THE STUDY REPORTED THAT THE DEVICE WAS TAKING TOO LONG TO CHARGE. THE PATIENT REPORTED THAT THE LONG CHARGING WAS CAUSING AN INCONVENIENCE AS THE CHARGING DURATION HAD INCREASED TO 8 HOURS. INTERROGATION OF THE DEVICES FOUND THAT BOTH HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR AND ONE HAD REACHED THE POINT OF THERAPY UNAVAILABILITY. THE GENERATOR WAS SCHEDULED TO BE REPLACED ON (B)(6) 2022. THE PATIENT REPORTED THAT THEY HAD A LOSS OF THERAPEUTIC RELIEF RELATED TO THE BATTERY DEPLETION. DURING THE REPLACEMENT FOR NORMAL BATTERY DEPLETION IT WAS FOUND THAT THE LEAD TIPS WHICH HAD BEEN IMPLANTED AT T5 AND T10 WERE AT T9/10 AND T11/12. IT WAS UNCLEAR IF BOTH LEADS MIGRATED OR ONLY THE LEAD WITH THE TIP AT T5. NO ADDITIONAL SURGICAL INTERVENTION WAS TAKEN. THE MIGRATION WAS UNRESOLVED WITH NO FURTHER ACTION PLANNED.

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

  MAUDE report 16757339 ↗
• MalfunctionApr 10, 2023Delayed Charge Time; Delayed Charge Time

  A RESPONSE WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING PATIENT'S COMPLAINT. REP REPORTS PATIENT HAD A DEVICE EXCHANGE BECAUSE THEIR PREVIOUS IPG'S HAD REACHED NORMAL END OF LIFE. PATIENT HAD THERAPY ISSUE; THE PROBLEM HAS BEEN SOLVED. THERE WERE NO EXTERNAL FACTORS THAT AFFECTED DEVICE OR THERAPY FUNCTIONALITY AND PATIENT WAS EDUCATED TO REDUCE MA TO CONSERVE ENERGY. A REDUCTION IN MA AND EDUCATED PT ON POSSIBLE PROGRAMMING OPTIONS AT FOLLOW UP APPOINTMENT (SWITCHING TO DTM ENDURANCE). PATIENT'S ISSUES HAVE BEEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709011 ↗
• InjuryJan 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THERE WAS A MALFUNCTION OF THE INS. IT WAS LATER NOTED THAT A SUCCESSFUL INS HAD BEEN IN PLACE, HOWEVER THE PATIENT REQUIRED AN MRI COMPATIBLE INS SYSTEM. THE PATIENT'S INS WAS REPLACED AND THERE WERE NO SURGICAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086631 ↗

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