Itrel® 4 37704Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169107809), received between Nov 23, 2016 and Oct 29, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJul 31, 2019Premature Discharge of Battery; Migration or Expulsion of Device; Battery Problem; Premature Discharge of Battery; Migration or Expulsion of Device; Battery Problem

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. INFORMATION WAS REPORTED THAT THE CALLER SAID IT DOES NOT WORK AND THE LITTLE PICTURE OF SAYS END OF SERVICE (EOS). THERE AN ALLEGATION OF DISSATISFACTION OF THE LONGEVITY OF THE PATIENT'S INS BATTERY. THE CALLER STATED THE PATIENT SAW THE EOS MESSAGE ON FRIDAY((B)(6) 2019), BUT THOUGHT THE INS WOULD LAST LIKE 10 YEARS. THE CALLER ALSO NOTED THAT THE PATIENT DOES NOT USE HIGH SETTINGS. THE CALLER ALSO NOTED THAT THE PATIENT HAS NOT HAD ANY FALLS, ACCIDENTS OR TRAUMAS HOWEVER THE PATIENT DID HAVE RHIZOTOMY FOR TMJ 2 WEEKS AGO, BUT THEY KNEW THEY HAD THE INS TURNED OFF FOR THE PROCEDURE. THE CALLER THEN STATED THE ERI OCCURRED ABOUT A MONTH AGO THEN WENT AWAY. THE CALLER ALSO NOTED THAT THE PATIENT HAD BEEN WITH A MANUFACTURING REPRESENTATIVE (REP) FOR REPROGRAMMING LAST WEEK ON MONDAY OR TUESDAY. THE CALLER WAS REDIRECTED TO THE PATIENT'S HEALTHCARE PROVIDER (HCP) TO DISCUSS THE NEXT STEPS. NO FURTHER COMPLICATIONS WERE REPORTED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8847777 ↗
• InjuryFeb 28, 2018Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE INS WAS AT END OF SERVICE (EOS). THE PATIENT STATED THEY WENT TO MAKE AN ADJUSTMENT WITH THE PATIENT PROGRAMMER, AND IT REFUSED TO DO ANYTHING. THE PATIENT CHANGED THE PROGRAMMER BATTERIES AND HE ENCOUNTERED THE EOS MESSAGE. THE PATIENT SAID THEY WERE TOLD IT WOULD LAST 10 YEARS. NO SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7303081 ↗
• MalfunctionNov 29, 2017Failure to Deliver Energy; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) VIA A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR POST LUMBAR LAMINECTOMY SYNDROME AND NON-MALIGNANT PAIN. THE PATIENT WAS SEEING THE LOW INS BATTERY ICON ON THEIR PATIENT PROGRAMMER. THEY HAVE NOT SEEN THE ELECTIVE REPLACEMENT INDICATOR (ERI) OR END OF SERVICE (EOS) MESSAGE. THE PATIENT COULD NOT FEEL STIMULATION 3 OR 4 WEEKS AGO SO THEY TURNED THE STIMULATION OFF. THEY TURNED IT ON TODAY AND FELT THE STIMULATION COME BACK ON BUT THEN NOTICED THE LOW INS BATTERY ICON. THE PATIENT HAS NEVER SEEN THIS ICON BEFORE. THE LOSS OF STIMULATION WAS CONSIDERED SUDDEN BUT COULD BE EXPECTED GIVEN THE AGE OF THE INS. THE REP WOULD FOLLOW UP WITH THE PATIENT TO DISCUSS FURTHER. NO FURTHER COMPLICATIONS WERE REPORTED/ARE ANTICIPATED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 7067564 ↗
• MalfunctionNov 23, 2016Inappropriate/Inadequate Shock/Stimulation; Device Operates Differently Than Expected; Inappropriate/Inadequate Shock/Stimulation; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT WAS GETTING A JOLT WHEN WORKING WITH THE PATIENT PROGRAMMER. THE CALLER WAS WORRIED THAT IT WAS TOO HIGH AND WANTED TO ENSURE THAT THE PATIENT WOULD NOT GET A SHOCK. THIS HAD HAPPENED A COUPLE OF TIMES AND A MANUFACTURER REPRESENTATIVE WAS INFORMED ABOUT IT WHEN MANUFACTURER REPRESENTATIVE HAD MET WITH THE PATIENT ON FRIDAY ((B)(6) 2016). ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REPORTING THAT WITH TROUBLESHOOTING THEY WERE ABLE TO USE THE PATIENT PROGRAMMER TO CONNECT, LOWER AMPLITUDE, AND TURN THE IMPLANTABLE NEUROSTIMULATOR (INS) ON. IT WAS REVIEWED TO SET STIMULATION AT A COMFORTABLE LEVEL.

  Patient problems: Device Overstimulation of Tissue; Electric Shock

  MAUDE report 6124088 ↗

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