Itrel® 4 37703Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00643169107793), received between Nov 22, 2016 and Apr 29, 2026 — classified as 27 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (19 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 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Intermittent Continuity; No Device Output; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT SAYS THAT THEIR IMPLANTED NEUROSTIMULATOR ISNT WORKING, AND IF THEY TURN IT ON IT GOES RIGHT BACK OFF. THEY CLARIFIED THAT THEY MEAN THE STIMULATION IN THEIR BODY. THEY SAID THIS STARTED HAPPENING ABOUT A MONTH AND A HALF AGO. PT SAYS THAT THE HEALTHCARE PROVIDER (HCP)  OFFICE SAID THAT THEY WERE GOING TO CALL BUT DOESN'T KNOW WHAT THE STATUS IS. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

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

  MAUDE report 25035144 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THE PATIENT HAD A BATTERY REPLACEMENT. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057095 ↗
• MalfunctionFeb 15, 2024High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT DURING AN IMPEDANCE CHECK, ELECTRODE 3 IS OUT OF RANGE AND GREATER THAN 10,000 OHMS; HOWEVER, THE PATIENT'S PROGRAMMING COVERS THE ORIGINAL AREAS OF PAIN AND THE PATIENT IS NOT USING ELECTRODE 3.  THERE WERE NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711372 ↗
• MalfunctionOct 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED REPLACEMENT WAS SCHEDULE FOR (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908780 ↗
• InjuryAug 15, 2023Battery Problem; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. THE REASON FOR CALL WAS PATIENT REPORTED THEIR BATTERY WAS 'DEAD' AND THEY WERE CHANGING OUT THE WHOLE SYSTEM. PATIENT WAS ESCALATED DURING THE CALL AND AGENT ATTEMPTED TO COLLECT MORE INFORMATION BUT PATIENT DISCONNECTED THE CALL. AGENT REDIRECTED PATIENT TO THEIR HEALTHCARE PROVIDER (HCP) TO DISCUSS REMOVAL/REPLACEMENT OF THE IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THEY ARE IN THE PROCESS OF HAVING THEIR INS REPLACED. CALLER INQUIRED ABOUT CLINICIAN PROGRAM APP REPORTING CAPABILITIES. PSS REVIEWED INFORMATION. CALLER STATED THEY HAVE A HEALTH ISSUE WITH THEIR EYE WHERE THEY NEED AN MRI BUT WAS TOLD THEY CANNOT HAVE ONE DUE TO THEIR SPINAL CORD SYSTEM (SCS) SYSTEM. PSS REVIEWED INFORMATION AND EMAILED PT MRI GUIDELINES TO PROVIDE TO THEIR HEALTHCARE PROVIDER (HCP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553001 ↗
• InjuryAug 7, 2023Failure to Interrogate; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Communication or Transmission Problem; Positioning Problem; Insufficient Device Problem Information; Failure to Interrogate; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Communication or Transmission Problem; Positioning Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT REPORTING THAT THEIR BATTERY WAS DEAD AND HAS TO BE REPLACED. AFTER THE INITIAL SHOCK, IT WAS REPORTED THAT IT STOPPED, BUT THE POUCH THEY MADE WAS SORE. THE PATIENT WAS IN THE PROCESS OF GETTING THE DEVICE REPLACED UPON EVALUATION BY THEIR DOCTOR ON SEPT 20TH. IT WAS REPORTED THAT THE STIMULATOR WAS NOT WORKING, TROUBLESHOOTING WAS DONE WITH THE MANUFACTURER CUSTOMER SERVICE, THE INTERNAL BATTERY WAS DEAD AND THE PATIENT WAS WAITING FOR AN APPOINTMENT WITH THEIR DOCTOR FOR AN EVALUATION AND POSSIBLE REPLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT REPORTING THAT THEIR DEVICE QUIT WORKING AND THEY ARE TALKING ABOUT PUTTING A NEW DEVICE IN. PATIENT SAID THEY SAW THE HEALTHCARE PROVIDER ON WEDNESDAY (SEPT 20) AND A MANUFACTURER REPRESENTATIVE (REP) CAME. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

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

  MAUDE report 17471072 ↗
• InjuryAug 2, 2023Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THERE WAS NO FUNCTIONAL COMPLAINT ABOUT THE LEAD. THE SURGEON HAD MADE A DECISION TO UPGRADE TO A SURESCAN PADDLE LEAD. THIS REPORT IS REGARDING THE BREAKAGE OF THE LEAD UPON ATTEMPT TO REMOVE. LEAD BROKE AS DESCRIBED ABOVE DUE TO LONG TERM SCARRING. ONLY THE DISTAL PORTION WITH CONTACTS IS LEFT IN THE BODY. THE CAUSE WAS SURGICAL DISSECTION AND SCARRING. PATIENT EXPERIENCED A DURAL TEAR DURING DISSECTION IN SURGERY TO REMOVE THE OLD LEAD. PATIENT WILL BE KEPT IN THE HOSPITAL FOR 2-3 NIGHTS TO ADDRESS RECOVERY FROM DURAL TEAR. A LUMBAR DRAIN WILL BE PLACED TO AID IN CSF LEAK STABILIZATION. PATIENT TO REMAIN IN THE HOSPITAL FOR 2-3 DAYS TO RECOVER FROM DURAL PUNCTURE. THE ISSUE WAS RESOLVED.

  Patient problems: Cerebrospinal Fluid Leakage; Device Embedded In Tissue or Plaque; Scar Tissue; Spinal Cord Injury

  MAUDE report 17445507 ↗
• InjuryMay 22, 2023Battery Problem; Adverse Event Without Identified Device or Use Problem; Battery Problem; Adverse Event Without Identified Device or Use Problem

  THE HCP REPORTED THAT THE CAUSE OF REPLACEMENT WAS BATTERY AT END OF LIFE. "MDR DECISION UPDATED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16978805 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; 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) FOR UNKNOWN INDICATIONS FOR USE. CALLER STATES PT HAD 37703 EXPLANTED ON (B)(6) 2017 BY HCP. CALLER STATES THE PATIENT HAS FAILED BACK SYNDROME AND REASON FOR EXPLANT WAS DUE TO THE SCS NO LONGER PROVIDING RELIEF AND PT EXPERIENCING PAIN AT THE INS SITE. CALLER REPORTS THE LEAD AND POSSIBLY THE EXTENSION ARE STILL IMPLANTED. CALLER INQUIRING IF PT CAN HAVE MRI.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; Pain

  MAUDE report 16022214 ↗
• InjuryDec 2, 2022Break; Break

  IT WAS REPORTED THAT PATIENT WAS SCHEDULED FOR A BATTERY AND EXTENSION REPLACEMENT TODAY. THE PROXIMAL END OF THE LEAD FRACTURED WHEN GETTING REMOVED FROM THE DISTAL END OF THE EXTENSION. THE LEAD AND EXTENSION ARE LEFT DISCONNECTED AND THE PATIENT WILL BE REFERRED FOR LEAD REVISION/BATTERY REPLACEMENT AT A FUTURE DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15905206 ↗
• InjurySep 24, 2022Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  2022-JUL-28 RTG0332903 (CON): INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. THE PATIENT REPORTED THAT THEY ARE NEEDING THEIR INS REPLACED AND WAS SUPPOSED TO HAVE REPLACEMENT SURGERY, BUT SURGERY WAS POSTPONED BECAUSE THE HCP NEEDS A LEAD REPLACED BEFORE THEY CAN IMPLANT THE NEW INS. PATIENT REPORTED THAT THEIR INS HAD DIED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON (B)(6) 2022. THEY REPORTED THEY FIRST NOTICED THAT THE INS HAD DIED IN (B)(6) 2022, AND HAD CONTACTED THE MANUFACTURER AT THAT TIME ABOUT IT. NOTHING HAS BEEN DONE YET. THEY DON'T KNOW WHY THE "WIRE" NEEDS TO BE REPLACED. THEY STATED THEIR SURGERY ON (B)(6) 2022 WAS POSTPONED AFTER THEY WERE IN THE SURGICAL ROOM AND "OUT". THE DOCTOR DECIDED THEY NEEDED ANOTHER ORTHOPEDIC DOCTOR TO HELP WITH THE SURGERY, WHOM THE PT ENDED UP SEEING ON AUGUST 30TH. PATIENT WEIGHT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15478847 ↗
• MalfunctionNov 10, 2021Electromagnetic Interference; Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Compatibility Problem; Electromagnetic Interference; Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Compatibility Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PT STATED THAT SOMETIMES WHEN THEY PASS BY COMPUTERS OR DIALYSIS MACHINES, OR WHEN THEY ARE NEAR THE AIR FORCE BASE BY WHERE THEY LIVE, THEIR INS TURNS OFF AND THEY GET ELECTROCUTED. PT CLARIFIED THAT THEY DON'T ACTUALLY GET ELECTROCUTED, BUT THAT IT FEELS LIKE A STATIC SHOCK. PT SAID THEY HAVE ALSO EXPERIENCED THIS WHEN GOING THROUGH SECURITY AND THEY HAVE LEARNED TO TURN THEIR INS OFF. PT SAID THIS HAS BEEN GOING ON SINCE THEY HAD THEIR FIRST IMPLANT IN 1999. THE PATIENT WAS DIRECTED TO FOLLOW-UP WITH THEIR HEALTHCARE PROVIDER.

  Patient problems: Electric Shock

  MAUDE report 12791159 ↗
• MalfunctionNov 10, 2021Failure to Deliver Energy; Failure to Deliver Energy

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT SINCE 2017-2018 THEY WEREN'T EXPERIENCING PAIN THAT MUCH, AND SO THEY TRIED NOT SWITCHING ON THEIR INS AND IT WAS WORKING FINE. PT SAID THEY WOULD ONLY USE THE INS WHEN THEY WERE HAVING BREAKTHROUGH PAINS, BUT IT WASN'T REGULAR. NOW, THE PT HAD A SURGERY ON THEIR STOMACH, AND THEY COULDN'T USE THEIR CRUTCHES BECAUSE IT WOULD PULL ON THEIR STOMACH, SHE THEN STARTED HAVING MORE BREAKTHROUGH PAINS. PT SAID FOR THE PAST FIVE MONTHS, WHEN THEY TURN ON THE INS, AFTER ABOUT 30 MINUTES IT WILL TURN OFF AGAIN; PT LATER CLARIFIED THAT IT IS NOT ALWAYS 30 MINUTES, BUT SOMETIMES SHORTER OR LONGER. TECH SERVICES RECOMMENDED KEEPING A LOG OF ALL THE TIMES THAT THE INS WAS TURNED ON AND WHEN THE PT SEES IT TURN OFF AND TO FOLLOW UP WITH THEIR HEALTHCARE PROVIDER AND THEIR MEDTRONIC REPRESENTATIVE. THE ISSUE WAS NOT RESOLVED. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Pain

  MAUDE report 12790398 ↗
• MalfunctionSep 28, 2021Failure to Deliver Energy; Failure to Deliver Energy

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT SOMETIMES THEIR INS WORKS, SOMETIMES IT DOESN'T. PT SAID THEY NEVER TURN THE INS OFF, BUT THEY DON'T FEEL IT WORKING ANYMORE. PT SAID THEY HAVE THE INS ON, BUT THEY ARE NOT FEELING THE VIBRATING IN THEIR BACK. PT SAID THAT THEY CAN PUSH IT UP TO 9 BUT STILL CAN'T FEEL IT. WHEN ASKED FOR EVENT DATE, PT SAID IT HAS BEEN GOING OFF AND ON FOR MOST OF THIS YEAR; PT SAID LATELY THE STIMULATOR HAS BEEN WORKING BUT TODAY IT WASN'T AT ALL. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.  PT SAID THEY HAVE BEEN GOING TO THE PAIN CLINIC IN STARKVILLE, MS AND TO THEIR SURGEON AT THE ORTHOPEDIC CLINIC IN (B)(6). THE PATIENT MENTIONED UNRELATED MEDICAL HISTORY INCLUDING THEY HAD A FUSION LAST SEPTEMBER. REDIRECTED CALLER: PATIENT'S HCP.

  Patient problems: Insufficient Information

  MAUDE report 12540295 ↗
• InjurySep 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 2021-MAY-12, INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PT SAID THEIR INS WAS NO LONGER WORKING AND NEEDED TO BE REPLACED. PT SAID IT HAD NOT WORKED FOR A LITTLE WHILE, AND SAID END OF LAST YEAR, MAYBE EARLIER. PT THEN SAID THEIR BACK WAS REALLY ACTING UP IN THE LAST MONTH OR SO AND THEY COULDN'T BEND DOWN TO PICK UP ANYTHING SO THEY WERE HOPING GETTING INS REPLACED WOULD HELP. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER (HCP) TO FURTHER ADDRESS THE ISSUE. PT SAID THEY ALREADY CALLED THE HCP OFFICE AND WAS TOLD TO CALL MDT TO GET IN TOUCH WITH A REP. ON (B)(6) 2021, ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT REPORTING THEIR INS WAS NOT WORKING ANYMORE. PT DID NOT KNOW WHEN IT STOPPED WORKING BUT NOTED THAT IT STOPPED WORKING AWHILE AGO. PT SAID THEY WERE SCHEDULED FOR A REPLACEMENT SURGERY NEXT WEEK ON FRIDAY (B)(6) 2021.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 12478222 ↗
• InjuryJul 29, 2021Break; Unintended Collision; Inappropriate/Inadequate Shock/Stimulation; Patient Device Interaction Problem; Break; Unintended Collision; Inappropriate/Inadequate Shock/Stimulation; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FAILED BACK SURGERY SYNDROME AND SPINAL PAIN. THE REASON FOR CALL WAS PT REPORTED THEY HAVEN'T BEEN ABLE TO USE THERAPY BECAUSE THEY WERE EXPERIENCING STRONG SHOCKING SENSATIONS. PT STATED THEY'VE HAD FALLS AND THINKS THE SHOCKING SENSATION MAY BE DUE TO FALLING. PATIENT SERVICES (PS) ATTEMPTED TO CLARIFY DATES OF THE FALLS AND WHEN THE SHOCKING SENSATIONS BEGAN AND PT STATED THEY'VE HAD A STROKE AND DON'T REMEMBER. PT EXPLAINED THAT AFTER THEY HAD THE STROKE, THEY DIDN'T REMEMBER THE DEVICE WAS IMPLANTED IN THEM. PT STATED THEY'VE FALLEN QUITE A BIT. PT ALSO MENTIONED THEY'VE HAD THREE DEVICES REPLACED AND CONFIRMED ALL THREE WERE DUE TO NORMAL BATTERY DEPLETION. PT DOES NOT CURRENTLY HAVE A MANAGING HCP AT THIS TIME AND STATED THEY HCP THEY WERE SEEING PASSED AWAY. THE PATIENT ALSO REPORTED THEY HAD A LEAD WIRE REPLACED DUE TO FALLING AND BREAKING THE LEAD. PATIENT SERVICES (PS) ATTEMPTED TO CONFIRM AN EVENT DATE AND PT STATED THEY DON'T REMEMBER.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249347 ↗
• MalfunctionJul 27, 2021No Device Output; Electromagnetic Compatibility Problem; Insufficient Device Problem Information; No Device Output; Electromagnetic Compatibility Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN AND COMPLEX REG PAIN SYNDROME TYPE I. PT HAD THEIR IMPLANT TURNED OFF FOR SURGERY AND NOW THE IMPLANT WOULD NOT TURN ON. WHEN PT ATTEMPTED TO USE THEIR PROGRAMMER THEY RECEIVED THE MESSAGE "BATTERY FAULT" AND A PICTURE OF A BATTERY WITH AN X. DURING CALL PT ATTEMPTED TO SYNC PROGRAMMER TO IMPLANT AND RECEIVED THE MESSAGE POR WITH A TRIANGLE. THE ISSUE WAS NOT RESOLVED. THERE WERE NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229752 ↗
• MalfunctionNov 2, 2020Battery Problem; Electromagnetic Compatibility Problem; Battery Problem; Electromagnetic Compatibility Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT AROUND TWO DAYS AGO THE PATIENT'S STIMULATION STOPPED WORKING BECAUSE EOS (END OF SERVICE) APPEARED. THE PATIENT NOTED THAT THEY THOUGHT THEY LEANED AGAINST A MAGNET THAT CAUSED THE EOS MESSAGE TO APPEAR. THE MEANING OF THE SCREEN WAS REVIEWED AND THE PATIENT WAS REDIRECTED TO FOLLOW-UP WITH THEIR HEALTHCARE PROVIDER (HCP). NO SYMPTOMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10776062 ↗
• MalfunctionAug 31, 2020Intermittent Continuity; Energy Output Problem; Insufficient Device Problem Information; Intermittent Continuity; Energy Output Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A CONSUMER CONCERNING PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). PATIENT STATED THAT JUST A COUPLE OF WEEKS AGO, HE IS NOT SURE IF HIS IMPLANT IS WEAK OR WHAT, BUT SOMETIMES IT GOES ON AND SOMETIMES IT DOES NOT WHEN THEY TRY TO TURN IT OFF. PATIENT STATED THAT HE HAD THE IMPLANT REPLACED IN 2018 (PATIENT DID NOT ALLEGE ANY ALLEGATION TO HIS PREVIOUS DEVICE). PATIENT CLARIFIED AND SAID HE TRIES TO TURN THE IMPLANT ON AND WHEN HE GOES TO TURN THE IMPLANT OFF, THE IMPLANT WILL NOT POWER OFF. PATIENT ADDED THAT SOMETIMES HE WILL NOT HAVE THE IMPLANT TURNED ON AND IT WILL COME ON BY ITSELF. PATIENT SAID HE HAS NOT HAD ANY FALLS OR TRAUMA. PATIENT WAS REDIRECT TO THEIR HEALTHCARE PROVIDER (HCP) TO CHECK THE IMPLANT.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 10470684 ↗
• MalfunctionMay 26, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT FOR A COUPLE OF MONTHS, PATIENT STATED SHE COULD NOT SLEEP, WAS FALLING A LOT, DIZZY, AND HAD TREMORS SO BAD SHE COULD NOT HOLD A FORK. PATIENT STATED THEY WERE LOSING WEIGHT AND INS WAS BULGING OUT. PATIENT STATED THEY HAD TO USE AN ADAPTOR AND IT WAS MAKING A HOLE IN THE HIP. PATIENT STATED LEADS WERE IN HEAD AND SHE WAS HAVING HUGE KNOTS IN THE BACK OF THEIR HEAD AND SOMETHING WAS POKING OUT. PATIENT STATED IT HURT TO TOUCH AND WAS IN SO MUCH PAIN IN THEIR HEAD AND NECK. PATIENT REPORTED THEY WERE IMPLANTED FOR MIGRAINES AND THAT THEY HAD A HISTORY OF SEIZURES SINCE BEFORE IMPLANT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED

  Patient problems: Complaint, Ill-Defined; Dizziness; Electric Shock; Fall; Pain; Scar Tissue; Shaking/Tremors; Sleep Dysfunction

  MAUDE report 10088562 ↗
• InjuryApr 28, 2020Battery Problem; Adverse Event Without Identified Device or Use Problem; Battery Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER AND HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT IN (B)(6) 2020, THE PATIENT WAS GETTING A REPLACEMENT INS DUE TO SEEING THE END OF SERVICE (EOS) MESSAGE. THE PROCEDURE WAS ABORTED. A LEAD REMAINED IMPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10004313 ↗
• InjuryMar 30, 2020Intermittent Continuity; Failure to Deliver Energy; High impedance; Electromagnetic Compatibility Problem; Intermittent Continuity; Failure to Deliver Energy; High impedance; Electromagnetic Compatibility Problem

  INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE FROM A CONSUMER REGARDING A PATIENT WHO IS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT HAD SURGERY 1-2 YEARS PRIOR TO THE REPORT AND EVER SINCE THEY TURNED THE IMPLANTABLE NEUROSTIMULATOR BACK ON AFTER SURGERY, THEY HAVE NOTICED THAT THE IMPLANTABLE NEUROSTIMULATOR TURNS OFF SPONTANEOUSLY ON ITS OWN. THE PATIENT WOULD FEEL STIMULATION TURN OFF AND THEN USE THEN PATIENT PROGRAMMER TO TURN IT BACK ON, AND THEN THE IMPLANTABLE NEUROSTIMULATOR WOULD TURN OFF AGAIN. THE BATTERY VOLTAGE WAS 2.585 VOLTS AND THE SERVICE LIFE SHOWS OK. THE PATIENT IS PROGRAMMED ON 0+ 1- 3+. IMPEDANCES WERE CHECKED AT 3.0 VOLTS AND PROVIDED THE FOLLOWING VALUES: REFERENCE 0 - C-291, 1-552, 2-40K, 3-557 REFERENCE 1 - C-552, 0-557, 2-40K, 3-873 REFERENCE 2 - ALL OVER 40K REFERENCE 3 - C-557, 0-665, 1-873, 2-40K THERE WERE NO MESSAGES OR ERRORS DISPLAYED ON THE CLINICIAN PROGRAMMER UPON INTERROGATION, AND THE PATIENT HAS NOT SEEN ANY ON THE PATIENT PROGRAMMER. NO ACTIONS WERE TAKEN TO RESOLVE THE STIMULATION TURNING ON/OFF ON ITS OWN. THE PATIENT WAS SENT HOME TO MONITOR WHEN THIS OCCURS. THERE WERE NO FURTHER COMPLICATIONS REPORT

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

  MAUDE report 9901820 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN AND RSD/CAUSALGIA-COMPLEX REGIONAL PAIN SYNDROME. INFORMATION WAS REPORTED THAT THE PATIENT STATED SHE HAS INFLAMMATION AT THE IMPLANT SITE AND WAS HOSPITALIZED FOR FIVE DAYS ((B)(6) 2019) DUE TO REDNESS AND SWELLING THAT WENT ALL AROUND HERABDOMEN LIKE IT WAS INFECTED. THE PATIENT CONTINUED STATING THAT IN ADDITION TO THE REDNESS AROUND HER ABDOMEN, SHE HAD WHAT LOOKED TO BE A CYST ON THE INS BATTERY. THE PATIENT STATED THAT THEY WERE GIVEN ANTIBIOTICS WHICH HELPED TO RESOLVED THE INFLAMMATION. THE PATIENT THEN MENTIONED THAT THIS IS THE THIRD TIME SHE HAS BEEN A FLARE UP, THE FIRST TIME BEING LAST SUMMER. THE PATIENT ADDED THAT THE FIRST TWO WERE JUST AT THE IMPLANT SITE AND THIS IS THE THIRD TIME THE SWELLING AND REDNESS WENT FROM HER BATTERY TO THE ONCE HIP AND THEN TO THE OTHER, AND HAD STARTED TO GO AROUND THE PATIENT'S BACK. NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: Cyst(s); Erythema; Granuloma; Swelling; Unspecified Infection

  MAUDE report 9616627 ↗
• MalfunctionJul 23, 2019Energy Output Problem; Energy Output Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). IT WAS REPORTED THAT THE PATIENT HAD A CLINICAL ASSESSMENT COMING UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 8816378 ↗
• MalfunctionApr 26, 2019Energy Output Problem; Insufficient Device Problem Information; Energy Output Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A CONSUMER AND FAMILY/FRIEND ABOUT AN IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTED FOR NON-MALIGNANT PAIN AND CHRONIC LOW BACK PAIN. IT WAS REPORTED VIA THE PATIENT'S HUSBAND THAT THE PATIENT HAD A LOSS OF THERAPY, AND WAS IN PAIN AND FORGOT HOW TO USE THE PATIENT PROGRAMMER. THE CALLER SAID THE REASON FOR HIS CALL WAS TO ASK FOR THE REPRESENTATIVE'S CONTACT INFO FOR THE AREA AS THEIR MANAGING DOCTOR WAS A 100 MILES AWAY. CALLER SAID THAT HE TRIED READING THE PATIENT PROGRAMMER MANUAL BUT WASN'T ABLE TO UNDERSTAND IT. PATIENT SERVICES OFFERED ASSISTANCE ON HOW TO USE THE PATIENT PROGRAMMER BUT CALLER SAID THE PATIENT WAS IN TOO MUCH PAIN TO BEEN THE PHONE RIGHT NOW. THEY HAD WANTED THE REP TO COME TO THEIR PRIMARY CARE PHYSICIAN CLINIC NEAR WHERE THEY LIVE AND IT WAS REVIEWED THEIR HCP CAN REQUEST A REP TO COME THERE. THEY NOTED THIS ISSUE STARTED A COUPLE WEEKS AGO. THE PATIENT CALLED BACK IN LATER THAT DAY, AND STATED THEIR INS WAS NOT WORKING, AND SHE NOTICED THIS ISSUE 2 WEEKS AGO. THE PAIN STARTED 2 WEEKS AGO AS WELL, AND IT HAS BEEN GETTING WORSE. THEY STATED THE PAIN WAS "COMING FROM THE BOX". PATIENT SERVICES ASKED IF THE PAIN WAS COMING FROM TH

  Patient problems: Dysphasia; Pain; Therapeutic Effects, Unexpected

  MAUDE report 8558496 ↗

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