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RestoreSensor 37714Recalls & reported problems

Medtronic, Inc. · INS 37714 SENSOR US MARKET · Class 3 · Implant

Quick summary

This Medtronic RestoreSensor spinal cord stimulator has 4,115 adverse event reports, including 1 death, 1,473 injuries and 2,641 malfunctions. The reports mostly describe battery and charging problems, unexpected device behavior, and units that stopped working and were later removed. No recalls name this device. Reports fell from 55 in the prior 12 months to 21 in the latest 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
4,116
Deaths reported
1
Injuries reported
1,474
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4,116 adverse event reports that list this exact device (DI 00613994610430), received between Jan 30, 2013 and Sep 24, 2026 — classified as 1 death, 1,474 injuries, 2,641 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (1,216 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.

Reports received per month

Nov 2023: 143 reportsDec 2023: 19 reportsJan 2024: 36 reportsFeb 2024: 42 reportsMar 2024: 13 reportsApr 2024: 6 reportsMay 2024: 7 reportsJun 2024: 6 reportsJul 2024: 12 reportsAug 2024: 5 reportsSep 2024: 5 reportsOct 2024: 6 reportsNov 2024: 5 reportsDec 2024: 3 reportsJan 2025: 5 reportsFeb 2025: 8 reportsMar 2025: 4 reportsApr 2025: 6 reportsMay 2025: 7 reportsJun 2025: 5 reportsJul 2025: 1 reportsAug 2025: 7 reportsSep 2025: 3 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 3 reportsJan 2026: 3 reportsFeb 2026: 1 reportsMar 2026: 5 reportsApr 2026: 3 reportsMay 2026: 2 reportsJun 2026: 2 reportsJul 2026: 1 reportsAug 2026: 1 reportsSep 2026: 1 reportsOct 2026: 0 reports202420252026143
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Battery Problem1,216
  • Charging Problem1,150
  • Device Operates Differently Than Expected699
  • Insufficient Device Problem Information672
  • Communication or Transmission Problem628
  • Failure to Deliver Energy584
  • Improper or Incorrect Procedure or Method495
  • Failure to Interrogate416

Patient problems

  • No Known Impact Or Consequence To Patient1,282
  • Therapeutic Effects, Unexpected1,022
  • Pain1,012
  • No Clinical Signs, Symptoms or Conditions712
  • Therapeutic Response, Decreased337
  • Electric Shock289
  • Complaint, Ill-Defined281
  • Discomfort198

Recent adverse event reports

The 25 most recent of 4,116 reports, in the reporter's own words as published by the FDA.

  • InjurySep 24, 2026Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information

    Information was received from a patient regarding an implantable neurostimulator. The reason for call was patient reported the stimulator never really worked for them despite programming adjustments for 6 months to a year. Patient stated they decided to stop charging the stimulator and no longer are using the stimulator. Patient stated they used to meet with manufacturer representatives (reps)  on and off. Patient stated 2.5-3 months ago, every time they lay down, the stimulator is shocking them. Patient stated it is the exact feeling that the device used to give them and it is keeping them from sleeping. Patient denied any falls, trauma, or excessive bending, twisting, or stretching that could have impacted the device. The patient was redirected to their healthcare provider to further address the issue. Patient mentioned they had a heart stent put in not too long ago about 3 months ago.

    Patient problems: Electric Shock; Sleep Dysfunction

    MAUDE report 50884840 ↗
  • InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    Patient mentioned that they were told that they still have a stimulator in there and they didn't know when the stimulator was taken out.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50442380 ↗
  • InjuryJul 2, 2026Degraded; Insufficient Device Problem Information

    INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THEIR PREVIOUS LEADS WERE CORRODED SO THEY HAD TO CHANGE EVERYTHING OUT AROUND 2023 OR (B)(6) OF 2023. PATIENT MENTIONED WHEN THEY INITIALLY CHANGED THE UNIT THEY SAW THAT THE LEADS WERE 'DEPLETED' SO WHEN THEY WENT BACK IN THAT SECOND TIME IN 2023 THAT WAS WHEN THEY CHANGED THE LEADS IF THEY REMEMBERED CORRECTLY. NO SYMPTOMS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25690813 ↗
  • InjuryJun 30, 2026Insufficient Device Problem Information

    INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). PT MENTIONED THEIR INS STOPPED WORKING SEVERAL YEARS AGO AND THEY STOPPED USING IT. TECHNICAL SERVICES (TSS) REVIEWED MRI INFORMATION AND REDIRECTED TO HEALTHCARE PROVIDER (HCP). PT MENTIONED THEY HAVE AN APPOINTMENT WITH THEIR HCP NEXT WEEK. ADDITIONAL INFORMATION WAS RECEIVED THAT THEIR STIMULATOR IS BEING REMOVED ON (B)(6) 2026.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25670702 ↗
  • InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS CALLER REPORTED THE PATIENT HAD THEIR STIMULATOR REMOVED IN 2017 BECAUSE THE PATIENT WAS STILL HAVING PAIN AND WAS NOT HAPPY. CALLER STATED THE LEAD REMAINS IMPLANTED BECAUSE THAT WOULD HAVE REQUIRED A MORE INVASIVE SURGERY. THE CALLER WAS NOT WITH THE PATIENT AT THE TIME OF THE CALL. CALLER MENTIONED THE PATIENT HAS HAD MRIS SINCE THE STIMULATOR WAS REMOVED AND HASN'T HAD ANY ISSUES AND THEIR LAST SPINE SURGERY WAS IN 2025.

    Patient problems: Device Embedded In Tissue or Plaque; Pain

    MAUDE report 25553281 ↗
  • InjuryMay 27, 2026Difficult to Remove; Insufficient Device Problem Information

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED THE STIMULATOR WAS REMOVED IN (B)(6) 2025 BECAUSE IT HAD NOT BEEN WORKING FOR PROBABLY A COUPLE YEARS AND THEIR INSURANCE WOULD NOT PAY TO REPLACE THE INS. PATIENT STATED THEY HAD A 12 HOUR BACK SURGERY AND THEY WAS NOT ABLE TO GET ALL THE WIRES OUT BECAUSE SOME OF THE WIRES WERE STUCK. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25302914 ↗
  • MalfunctionMay 26, 2026Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT REPORTED THEY WERE FEELING ELECTRICAL SHOCKS ALL THROUGHOUT THEIR BODY AND THE ISSUE WAS AFFECTING THEIR SLEEP. PATIENT MENTIONED THEY WANTED TO GET THE IMPLANT REMOVED BECAUSE IT HADN'T WORKED EVER SINCE IT WAS IMPLANTED IN 2012. PATIENT TURNED OFF THEIR IMPLANT PROBABLY IN 2013. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Patient problems: Electric Shock; Sleep Dysfunction

    MAUDE report 25280613 ↗
  • InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). REP REPORTS SYSTEM HAD BEEN EXPLANTED AT AN UNKNOWN EARLIER DATE. REP REPORTS INS SITE WAS FULLY HEALED; THEY BELIEVE REMOVAL SURGERY WAS OVER 1 YEAR AGO. REP REPORTS THE PATIENT REPORTED INSUFFICIENT/LACK OF RELIEF. REP WAS UNABLE TO CONFIRM IF THE PATIENT NEVER RECEIVED ADEQUATE THERAPY OR IF THE PATIENT HAD A CHANGE IN THEIR THERAPY. LOCATION OF REMOVED SPINAL CORD STIMULATOR WAS UNKNOWN. REP REPORTS THEY WERE NOT PRESENT FOR REMOVAL AND HAD NO FURTHER DETAILS.

    Patient problems: Insufficient Information

    MAUDE report 25005555 ↗
  • InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

    PATIENT MENTIONED THEY HAD THEIR IMPLANT BATTERY REPLACED IN OCTOBER OF LAST YEAR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24925290 ↗
  • InjuryApr 17, 2026Charging Problem

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). PATIENT MENTIONED THEY HAD THE BATTERY REPLACED IN 2015 BECAUSE THE BATTERY DIDN'T CHARGE ANYMORE. PT DID NOT HAVE ANY FURTHER INFORMATION ON WHEN THIS OCCURRED WHERE SHE STARTED TO HAVE ISSUES OR WHAT MODEL WAS PUT IN. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. NO SYMPTOMS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24913089 ↗
  • InjuryMar 31, 2026Insufficient Device Problem Information

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT REPORTED THEIR IMPLANT BATTERY WENT BAD AND THE ISSUE BEGAN PROBABLY IN 2019 OR 2020 OR THEY DIDN'T REMEMBER HOW LONG AFTER THE IMPLANT WAS IMPLANTED THAT THEY HAD ISSUES. PATIENT STATED WHEN THEY HAD THE IMPLANT IMPLANTED IT WAS ON ALL THE TIME AND IT WAS A VERY LOW VOLTAGE. THERE WERE A COUPLE LEADS BACK THEN THAT WEREN'T WORKING BUT THEY COULD STILL USE THE IMPLANT OR IT WAS FUNCTIONAL. THEY KNEW THE LEADS WERE BAD AND HAD BEEN BAD FOR A LONG TIME. THE IMPLANT WENT BAD RIGHT BEFORE COVID AND THEY NEEDED TO HAVE THE IMPLANT REPLACED AS WELL AS THE LEADS THAT WENT BAD. PATIENT COULDN'T DEAL WITH THE PAIN WITH THE IMPLANT NOT FUNCTIONING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Patient problems: Insufficient Information; Pain

    MAUDE report 24741239 ↗
  • MalfunctionMar 19, 2026Battery Problem

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT MENTIONED THEIR SPINAL CORD STIMULATOR HAD NOT BEEN WORKING FOR AT LEAST 7 YEARS. PATIENT SAID THEY TRIED TO CHARGE THEIR IMPLANTED NEUROSTIMULATOR AT ONE POINT WITH MANUFACTURER REPRESENTATIVE (REP) AT LEAST 7 YEARS AGO, BUT THE CHARGE WOULD NOT HOLD AT ALL AND THE PATIENT GAVE UP ON CHARGING THE IMPLANTED NEUROSTIMULATORS AT THAT TIME. PATIENT NOW NEEDED AN MRI OF THEIR NECK, BUT HEALTHCARE PROVIDER WANTED TO DO A WHOLE SPINE MRI AS WELL. AGENT REVIEWED MRI GUIDELINES WITH THE PATIENT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. NO SYMPTOMS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24640648 ↗
  • InjuryMar 18, 2026Migration or Expulsion of Device

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. PATIENT STATED THEIR LEADS MIGRATED AND THE HCP WENT IN AND PULLED THEM BACK TO THE RIGHT SPOT. PATIENT COULD NOT RECALL EVENT DATE. PATIENT ALSO STATED, AT WHAT AGENT UNDERSTOOD AS A DIFFERENT TIME, THEY THOUGHT HCP WHO WAS JUST A PAIN DOCTOR/ANESTHESIOLOGIST WAS GOING TO REMOVE EVERYTHING BUT WERE TOLD AFTERWARD THAT THE LEADS WERE STILL THERE AND YOU CAN SEE THE LEADS DANGLING ON AN XRAY. AGENT DOCUMENTED INFORMATION GIVEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24629767 ↗
  • InjuryMar 16, 2026Insufficient Device Problem Information

    ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED THE PATIENT CLARIFIED THAT THE PREVIOUS BATTERY AND WIRES FAILED OVER TIME. THE PATIENT'S BATTERY FAILED COMPLETELY FIRST AND THEN THE WIRES BIT BY BIT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24604799 ↗
  • InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

    BRAIN MRI. CALLER DID X-RAY TO CHECK FOR PRESENCE OF SCS SYSTEM AND SEES A LEAD REMNANT IN THE T6-8 AREA. REVIEWED HEAD ONLY CONDITIONS. WHEN CALLER ASKED THE PATIENT, THE PATIENT INDICATED THEY HAD THEIR SCS SYSTEM REMOVED 6+ YEARS AGO. FURTHER DETAILS IN SECURE NOTE. UPDATE TO PRS SENT VIA RTG.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 24482353 ↗
  • InjuryFeb 23, 2026Insufficient 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 THE PATIENT'S LEAD WAS DYSFUNCTIONAL. THE LEAD WAS EXPLANTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24413336 ↗
  • MalfunctionJan 30, 2026Charging Problem

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT SAID THAT THEIR "N EUROPATHY STARTED GETTING REALLY BAD", AND SAYS THIS STARTED A COUPLE YEARS AGO AND "THIS LAST YEAR HAS BEEN REALLY BAD" AND SAID THEY CANT CHARGE THEIR INS BATTERY. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. MAILED HCP LISTINGS TO THE PATIENT. REVIEWED MRI GUIDELINES.

    Patient problems: Neuropathy

    MAUDE report 24221865 ↗
  • InjuryJan 15, 2026Insufficient Device Problem Information

    INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). PATIENT MENTIONED THEIR PRIOR INS DIDN'T LAST AS LONG AS IT WAS SUPPOSED TO - PATIENT SAID THE BATTERY DIDN'T 'DIE,' BUT IT STOPPED 'WORKING RIGHT.

    Patient problems: Insufficient Information

    MAUDE report 24084726 ↗
  • InjuryJan 2, 2026Extracardiac stimulation; Therapy Delivered to Incorrect Body Area

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) VIA A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT REPORTS A SHOCKING/TINGLING SENSATION FROM THE BATTERY. BATTERY HAS BEEN OFF FOR MONTHS AND IS AT END OF LIFE. SURGEON PLANS TO EXPLANT OR REPLACE DEPENDING ON PATIENT PREFERENCES. UNABLE TO INTERROGATE SYSTEM.

    Patient problems: Electric Shock; Paresthesia

    MAUDE report 23950592 ↗
  • MalfunctionDec 23, 2025Overheating of Device; Overheating of Device

    INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS STARTING 2 OR 3 MONTHS AGO WHEN THE PT WAS ATTEMPTING TO RECHARGE THE INS IT DID NOT SEEM TO BE WORKING AS IT SHOULD BECAUSE THE INS WAS OVERHEATING WHEN CONNECTING. THE PTS BACK WOULD HURT AND OVER HEAT. PT WAS NOT GETTING ANY ERROR MESSAGES WHEN TRYING TO CHARGE INS. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. AGENT PROVIDED NAS PHONE NUMBER.

    Patient problems: Burning Sensation; Pain

    MAUDE report 23882283 ↗
  • MalfunctionDec 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    PT IS NEEDING MRI OF THE SHOULDER. HCP REPORTS PT SAID THE DOCTOR "CUT IT OFF" AND THE INS IS NOT WORKING ANYMORE. HCP UNABLE TO CLARIFY FURTHER. EVENT DATE PROVIDED: "SEVERAL YEARS AGO".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23716721 ↗
  • InjuryDec 3, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS THE PATIENT REPORTED MEDICAL HISTORY: THAT THEY HAD A SPINAL CORD STIMULATOR ORIGINALLY THAT THE HCP TOOK OUT BECAUSE IT WASN'T WORKING AND THEY HAD SO MANY SURGERIES BECAUSE THE LEAD KEPT BREAKING AND IT DIDN'T HELP FOR THEIR PAIN ANYWAY SO THEY TOOK IT OUT.

    Patient problems: Insufficient Information; Pain

    MAUDE report 23707580 ↗
  • MalfunctionOct 27, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

    IT WAS REPORTED THAT A PATIENT WITH A PAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) SPINAL CORD STIMULATOR EXPERIENCED BURNING SENSATIONS AND JOLTS OF SHOCKS IN THE MIDDLE OF THE BACK AND AT THE LOCATION WHERE THE BATTERY IS IMPLANTED. INVOLUNTARY URINARY LEAKAGE WAS ALSO REPORTED, WHICH WAS ATTRIBUTED TO THE JOLTING SHOCK.

    Patient problems: Burning Sensation; Electric Shock; Incontinence

    MAUDE report 23396692 ↗
  • MalfunctionSep 25, 2025Break; Connection Problem; Break; Connection Problem

    IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) REPORTS THAT THE DOCTOR CONTACTED HIM ON FRIDAY TO REPORT THAT THEY DID AN INS REPLACEMENT ON (B)(6) 2023. DR REPORTS THAT THEY HAD TROUBLE REMOVING THE LEAD FROM THE OLD INS AND THEN THEY HAD TROUBLE INSERTING THE LEAD INTO THE NEW INS. DR THINKS THE LEAD CONTACT WAS "CRUSHED". DR REPORTS THAT THEY WERE UNABLE TO INSERT THE LEAD ALL THE WAY INTO THE NEW INS AND THE LAST CONTACT IS OUTSIDE THE INS HEADER. REP SAID THE DR IS NOT PLANNING ON REPLACING THE LEAD. REP DID NOT HAVE THE PATIENT (PT) INFORMATION AT TIME OF CALL TO TECHNICAL SERVICES (TS).

    Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

    MAUDE report 23144728 ↗
  • InjurySep 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT SINCE TODAY, THEY WERE HAVING A HARD TIME CHARGING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AND CONTROLLER. PATIENT STATED THAT THE CONTROLLER BATTERY WAS AT 60% AND THE INS AT 50% BUT WHEN THEY ATTEMPT TO CHARGE THE INS IT WOULD SAY POOR RECHARGE QUALITY OR TERMINATED AND WHEN THEY CONNECTED THE CONTROLLER TO THE AC POWER SUPPLY IT WOULD NOT BLINK GREEN. PATIENT ALSO MENTIONED DURING THE CALL THAT THE CONTROLLER SHOWED A BATTERY LOW RECHARGE CONTROLLER MESSAGE BUT THE BATTERY ON THE CONTROLLER WAS STILL AT 60%. AGENT WALKED PATIENT THROUGH RESETTING THE CONTROLLER USING THE AC POWER SUPPLY. PATIENT CONFIRMED THE CONTROLLER POWERED ON. PATIENT CONFIRMED THE CONTROLLER WAS RECHARGING. PATIENT ALSO INSPECTED FOR DAMAGES AND SAW NO DAMAGES ON THE BATTERY PACK, CONTROLLER COMPARTMENT, AND RECHARGER. PATIENT ATTEMPTED TO START A CHARGING SESSION, AND THE CONTROLLER WAS STUCK AT THE CHECKING RECHARGE QUALITY SCREEN UNTIL THE CONTROLLER WENT TO SLEEP. PATIENT ATTEMPTED TO UNLOCK THE CONTROLLER, AND IT STARTED CHARGING THE INS WITH EXCELLENT QUALITY. AFTER A FEW MOMENTS WITHOUT THE PATIENT MOVING, THE CONTROLLER SHOWED A POOR RECHARGE QUALITY MESSAGE. THE ISSUE WAS NOT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23093061 ↗

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

Other STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.