RestoreULTRARecalls & reported problems across all models

We found 2 models of RestoreULTRA by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 253 adverse event reports in the FDA's MAUDE database, received between May 2, 2014 and Jun 25, 2025 — classified as 95 injuries, 158 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (75 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported RestoreULTRA problems

RestoreULTRA models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RestoreULTRA™ 37712

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  249 reports
• RestoreULTRA™ 37712

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  4 reports

Recent RestoreULTRA adverse event reports

The 15 most recent reports across all models, 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 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls