RestoreULTRA™ 37712 (UDI 00613994842336)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994842336), received between Sep 29, 2014 and Mar 16, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Battery Problem” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2023Break; Battery Problem; Insufficient Device Problem Information; Break; Battery Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT (PT) ON 2023-04-18. THE PT REPORTED THAT THEY HAD POOR PAIN COVERAGE AND THE INS WOULD NOT GO INTO MRI MODE. ISSUE WAS RESOLVED WITH A NEW MEDTRONIC SYSTEM REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554630 ↗
• MalfunctionJan 7, 2020Material Frayed; High impedance; Overheating of Device; Inappropriate/Inadequate Shock/Stimulation; Material Frayed; High impedance; Overheating of Device; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A CONSUMER AND MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR OTHER CHRONIC/INTRACT PAIN (TRUNK/LIMBS), CERVICAL/NECK, AND SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT HAD 2 IMPLANTED SYSTEMS. THE PATIENT WENT TO CHARGE THE RIGHT IMPLANTABLE NEUROSTIMULATOR (INS) AND THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) SHOWED IT WAS TOO HOT. THE PATIENT TURNED OFF THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) AND TURNED IT BACK. WHEN IT WAS TURNED ON IT WAS LIKE A BLOW OUT, IT WAS A SHOCK AND BURN THAT LEFT A BIG WELT ON THEIR BACK. THEY COULD FEEL THE SHOCK ALL THE WAY TO THEIR NECK. THE CONSUMER COULD HARDLY BET BACK INSIDE THE PATIENT PROGRAMMER TO TURN IT DOWN. THE PATIENT COULD NOT EAT AND REALLY THOUGHT THEY BURNED SOMETHING. THEY WERE SHOCKED WHILE CHARGING THE INS WHICH RESULTED IN A BURN ON THEIR SKIN. THERE WERE NO RELATED FALLS OR TRAUMAS. THE MANUFACTURER REPRESENTATIVE SAW THE PATIENT ON (B)(6) 2019. THE LEFT INS HAD IMPEDANCES >10000 OHMS ON EVERY CONTACT AND WERE PLACED PERIPHERALLY IN THE BACK OF THE PATIENT'S NECK. THE PATIENT HAD GREAT DISCOMFORT AND THEY DID NOT WANT TO BE PROGRAMMED. THE

  Patient problems: Burning Sensation; Complaint, Ill-Defined; Discomfort; Electric Shock

  MAUDE report 9560710 ↗
• InjuryApr 2, 2018Migration or Expulsion of Device; No Device Output; Device Or Device Fragments Location Unknown; Malposition of Device; Battery Problem; Charging Problem; Device Operates Differently Than Expected; Migration or Expulsion of Device; No Device Output; Device Or Device Fragments Location Unknown; Malposition of Device; Battery Problem; Charging Problem; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR CERVICAL/NECK AND SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT GOT SOME STUFF PUT IN HIS NECK THAT IS WORKING GREAT, SO HE DOESN¿T NEED THE STIMULATOR ANYMORE. THE PATIENT HADN¿T USED THE STIMULATOR IN A YEAR AND IT BOTHERED HIM TO HAVE SOMETHING IN HIS BODY THAT HE WAS NOT USING AND NO LONGER NEEDED. IT WAS ALSO MENTIONED THE PATIENT LOST SOME WEIGHT. THE PATIENT SAID THE WIRES RUN UP HIS NECK AND THE BATTERY IS IN HIS SIDE. THE PATIENT SAID THEY CUT HIM FROM HIS CROWN THROUGH THE EDGE OF HIS BACK AND STRETCHED HIM UP. THE PATIENT UNDERSTOOD THAT THEY PUT SOME GOLD STRIPS IN THERE AND THE WIRES RAN TO IT AND SCREWED IT AND GLUED IT. LATER IN THE CALL, THE PATIENT SAID THERE WERE THIN METAL STRIPS IN HIS NECK. THE PATIENT ALSO REPORTED BECAUSE OF PLACEMENT, IT MOVES. THE PATIENT SAID DURING IMPLANT SURGERY, HE WAS DROPPED OFF THE TABLE AND INJURED. THE PATIENT HAD HEP C AND SPENT 10 DAYS IN THE HOSPITAL. THE PATIENT SAID HIS SHOULDER WAS M ESSED UP. THE PATIENT SAID THAT THE STIMULATION CAUSED MUSCLE SPASMS ON A REGULAR BASIS. THE PATIENT ALSO SAID THE INS WENT DEAD AND THE P

  Patient problems: Complaint, Ill-Defined; Fall; Injury; Muscle Spasm(s); Pain; Weight Changes

  MAUDE report 7390165 ↗
• InjurySep 29, 2014Break; Failure to Deliver Energy; High impedance; Low impedance; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPEDANCE ISSUE OCCURRED ¿YEARS¿ AFTER SURGERY. THE IMPEDANCES DID NOT RESOLVE. THE CAUSE OF ISSUE WAS DETERMINED TO BE THAT SPECIFIC CONTACTS WERE OUT OF RANGE AND NOT ABLE TO BE USED IN PROGRAMMING. THE CONTACTS WITH THE SPECIFIC IMPEDANCE ISSUES WERE PROGRAMMED AROUND. THE PATIENT REPORTED GOOD COVERAGE AND PARESTHESIA UPON LEAVING THE VISIT. THERE WAS NO OTHER TROUBLESHOOTING, INTERVENTION OR OTHER ACTION TAKEN TO RESOLVE THE EVENT KNOWN TO THE MANUFACTURER REPRESENTATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Therapeutic Effects, Unexpected

  MAUDE report 4125373 ↗

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