Itrel 4Recalls & reported problems across all models

We found 2 models of Itrel 4 by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2016 and Apr 29, 2026 — classified as 29 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (20 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 Itrel 4 problems

Itrel 4 models

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

• Itrel® 4 37703

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  60 reports
• Itrel® 4 37704

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

Recent Itrel 4 adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryOct 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). CALLER STATED THE PATIENT (PT) "CODED ON THE TABLE TODAY DURING A CT SCAN" AND WAS ADMITTED INTO THE HOSPITAL. CALLER STATED IT APPEARS THAT THE LEAD IS ATTACHED TO PT'S DIAPHRAGM AND STATED THE PT SAID THE INS WAS IMPLANTED TO TARGET BREAST PAIN. CALLER ALSO STATED PT'S DIAPHRAGM IS IN THE WRONG POSITION. CALLER REQUESTED TO HAVE A MANUFACTURER REPRESENTATIVE COME TO THE HOSPITAL TO INSPECT THE INS TO SEE IF IT IS WORKING PROPERLY. FURTHER INFORMATION RECEIVED FROM THE HCP REPORTED THAT IT WAS UNKNOWN IF THE DEVICE OR THERAPY WAS CAUSAL TO THE REPORTED ISSUES. THEY NOTED THEY ONLY IMPLANTED THE GENERATOR AND NOT THE LEAD. IT WAS UNKNOWN IF THE ISSUE HAD BEEN RESOLVED. IT WAS NOTED THAT THE THERAPY HAD BEEN SUCCESSFUL IN RELIEVING THE PT¿S PAIN BEFORE AND AFTER THE EPISODE.

  Patient problems: Insufficient Information

  MAUDE report 15696101 ↗
• 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 ↗

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