RestoreSensor™SureScan® 97714Recalls & reported problems

Summary

The FDA's MAUDE database contains 17,903 adverse event reports that list this exact device (DI 00643169109483), received between May 19, 2014 and Sep 29, 2026 — classified as 6 deaths, 6,141 injuries, 11,756 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (5,262 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 17,903 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937998 ↗
• InjurySep 29, 2026Improper or Incorrect Procedure or Method; Battery Problem

  Patient problems: Pain

  MAUDE report 50937327 ↗
• MalfunctionSep 29, 2026Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935102 ↗
• InjurySep 29, 2026Failure to Deliver Energy

  Patient problems: Insufficient Information

  MAUDE report 50932350 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50926357 ↗
• MalfunctionSep 28, 2026Connection Problem; Material Integrity Problem

  Information was received from a patient regarding an external device. The reason for call was patient mentioned the connector pin on the desktop charger was loose, which they noticed today. A request was sent to the repair department to replace the desktop charger.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911429 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a patient (pt) regarding an implantable neurostimulator. Patient stated they had a lot of pain even with the stimulator. Patient stated that it helped and sometimes they can walk but they are still in a lot of pain. No additional information was provided.

  Patient problems: Pain

  MAUDE report 50897305 ↗
• MalfunctionSep 24, 2026Improper or Incorrect Procedure or Method; Battery Problem; Charging Problem

  Information was received from a patient (pt) regarding their implantable neurostimulator (INS). The reason for call was PT was not able to recharge the INS for the INS would start recharging and then show a picture of a doctor saying "FOP". PT noted when they had breast cancer and did radiation it did this too in 2020. They then came to their cancer center and restarted it and got it going again. This happened twice during that time where they could not recharge the INS; after getting the INS restarted twice they had been recharging the INS ever since. During call PT confirmed they were getting end of service (EOS). The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881602 ↗
• InjurySep 23, 2026Break

  Information was received from a healthcare provider regarding an implantable neurostimulator (INS). The caller stated that there was an op report written on (b)(6) 2025 that said there was a replacement of a fractured lead with a paddle lead. The caller did not have other details like when the lead became damaged. The issue was not resolved through troubleshooting. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869136 ↗
• InjurySep 21, 2026Malposition of Device; Adverse Event Without Identified Device or Use Problem

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Loss of Range of Motion; Nerve Damage; Numbness; Pain; Sleep Dysfunction; Spinal Cord Injury

  MAUDE report 50848343 ↗
• InjurySep 21, 2026Improper or Incorrect Procedure or Method; Battery Problem

  Information was received from a patient regarding an implantable neurostimulator. The reason for call was patient reported the implant battery ran out of operational use about 4-5 years ago. Agent asked, patient said they weren't using the implant that much before and wasn't charging as often because they were managing their pain and the implant 'didn't provide any additional value.' Agent understood patient voluntarily ceased the use of therapy over time, and the INS reached EOS. Patient mentioned they had no plan to put another INS battery in as a replacement right now, but needed to be able to get an MRI. Agent reviewed MRI eligibility form could be filled out on patient's behalf.

  Patient problems: Insufficient Information

  MAUDE report 50841370 ↗
• InjurySep 18, 2026Failure to Interrogate; Improper or Incorrect Procedure or Method; Battery Problem; Charging Problem; Communication or Transmission Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829583 ↗
• InjurySep 17, 2026Break; Battery Problem; Insufficient Device Problem Information

  Patient problems: Pain

  MAUDE report 50809274 ↗
• InjurySep 14, 2026Insufficient Device Problem Information

  Patient problems: Pain; Sleep Dysfunction

  MAUDE report 50763128 ↗
• MalfunctionAug 19, 2026Charging Problem; Connection Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50315379 ↗
• MalfunctionAug 7, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50173747 ↗
• InjuryJul 29, 2026Failure to Interrogate; Energy Output Problem; Improper or Incorrect Procedure or Method; Battery Problem; Communication or Transmission Problem; Insufficient Device Problem Information

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). Pt called and reported an inability to turn off stimulator. Pt stated they had not used the neurostimulator for 10 years and were attempting to turn it off for MRI but device would not connect. Pt stated INS did not work. Pt reported feeling uncomfortable when increasing stimulation and described sensation as being electrocuted. Agent reviewed over discharged and EOS to patient. Agent reviewed MRI eligibility form. Pt stated they already have the form. Agent redirected pt to their healthcare provider (HCP) and manufacturer representative (rep) for further assistance

  Patient problems: Device Overstimulation of Tissue; Discomfort

  MAUDE report 50070977 ↗
• InjuryJul 15, 2026Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT REPORTED THERE HAD BEEN A PROBLEM IN THE PAST AND THEY WERE TOLD THEY NEEDED TO HAVE THEIR OLD INS BATTERY REPLACED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). REP REPORTED THAT THEY WERE NEVER NOTIFIED THAT THE INS NEEDED REPLACEMENT. REP SAID THE PROBLEM THAT LED TO REPLACEMENT WAS PATIENT COMPLIANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25832024 ↗
• InjuryJul 15, 2026Battery Problem

  PT IS NEEDING MRI OF HER BACK BUT CLAIMS THAT BOTH STIMULATORS HAVE BEEN "DEAD FOR AWHILE" AND PT DID NOT BRING HER CONTROLLER TO THE MRI APPT. CALLER IS NOT SURE IF PT HAS ATTEMPTED TO RECHARGE THE STIMULATORS. RECOMMENDED PT ATTEMPT TO RECHARGE INS AND FOLLOW-UP W/ HCP IF SHE IS UNABLE TO. RECOMMENDED STIMULATORS BE PUT INTO MRI MODE PRIOR TO SCANNING. INFORMATION WAS REC'D FROM AN HCP STATED THAT PATIENT'S INS'S WERE REPLACED EARLY BECAUSE PATIENT WASN'T CHARGING THEM PROPERLY SO THEY ENDED UP COMPLETELY DEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25826183 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT'S ENTIRE SYSTEM WAS EXPLANTED BECAUSE IT BECAME INFECTED. THE PATIENT COULDN'T REMEMBER THE EXACT EXPLANT DATE.

  Patient problems: Unspecified Infection

  MAUDE report 25823875 ↗
• InjuryJul 7, 2026Battery Problem

  INFORMATION WAS RECEIVED FROM PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT MENTIONED THAT THEY WILL HAVE A SURGERY ON THE (B)(6) TO REPLACE THE IMPLANT BATTERY. PATIENT MENTIONED THAT PROBABLY 4 MONTHS AGO, THEY STARTED RECEIVING THE MESSAGE THAT THE BATTERY IS AT THE END OF ITS LIFE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25736633 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM PATIENT REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS CALLER STATED THAT THE PATIENT'S NEW HCP WAS TRYING TO SET THEM UP FOR MRI AND THEY ARE TRYING TO FIGURE OUT WHAT THEY NEED TO DO TO GET AN MRI. CALLER MENTIONED THAT THEY HAVE BEEN IN THE HOSPITAL SINCE THEY TRIED GETTING A NEW IMPLANT BUT STATED THAT SOMETHING WENT WRONG AND THEY DID NOT GET A NEW INS. CALLER STATED THAT THEY THINK DUE TO THE PATIENT'S HEALTH. CALLER STATED THAT THEIR INS WAS SHAKING THE PATIENT'S BODY. CALLER MENTIONED THAT THEY HAVE NOT BEEN CHARGING THEIR INS FOR A WHILE NOW PROBABLY A YEAR AND WHEN THEY CHARGE IT, THEY MET WITH "SOMEONE "TO CHARGE THE INS. CALLER STATED THAT THEY HAVE TWO PROGRAMMERS BIGGER AND SMALLER AND BOTH DOES NOT POWER ON. CALLER STATED THAT MRI IS A REQUEST OF THEIR NEW HCP AS THE PREVIOUS ONCE RETIRED. AGENT REVIEWED INFORMATION AS WELL AS PROVIDED MRI EDIBILITY FORM THAT THEY CAN USE. 2026-JUN-30 (B)(6) (CON): NO NEW INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 25726974 ↗
• InjuryJul 2, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT THERE WAS LEAD MIGRATION/DISLODGEMENT. THE LEAD WAS REPLACED AND THE ISSUE WAS RESOLVED. 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 25689982 ↗
• MalfunctionJun 29, 2026High impedance; Adverse Event Without Identified Device or Use Problem

  Additional information was recieved from the rep after an outbound call was made to rep. Rep confirmed patient information. Cause of high impedance was not known. They changed everything out on (b)(6) and put in a whole new system, issue resolved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25652238 ↗
• InjuryJun 25, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FIRST IMPLANTABLE NEUROSTIMULATOR (INS) THEY HAD FROM 2015 QUIT WORKING AFTER A FEW YEARS, SO THAT'S WHY THEY HAD THEIR CURRENT INS IMPLANTED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630446 ↗

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