Specify® SureScan® MRI 2x8 977C265Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169464650), received between Jun 19, 2017 and Nov 13, 2025 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “High impedance” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEVICE SET WAS COMPLETELY EXPLANTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23542476 ↗
• InjuryFeb 2, 2023Adverse 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) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE HCP ADVISED THAT THE PATIENT HAD A DURAL TEAR AFTER HE PERFORMED A LAMINECTOMY. THE HCP ABORTED THE CASE AND TREATED THE DURAL TEAR BEFORE CLOSING HIS INCISION. THE LEAD WAS NEVER IMPLANTED. THE ISSUE WAS RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 16283714 ↗
• InjuryApr 25, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS IN THE OPERATING ROOM ON THE TABLE. THE DOCTOR HAD PLACED THE LEAD AND TUNNELED TO CONNECT THE LEAD TO THE BATTERY. JUST BEFORE CONNECTING THE LEAD TO THE BATTERY, THE NEURO MONITORING TECHNICIAN TOLD THE DOCTOR THAT THEY HAD LOST SIGNALS ON THE RIGHT SIDE. THE DOCTOR AND TECHNICIAN DISCUSSED THIS FURTHER AND THEN THE DOCTOR DECIDED TO NOT IMPLANT THE LEAD OR BATTERY. UNKNOWN IF THE PRODUCT WAS REPLACED AND THE LEAD AND BATTERY WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196506 ↗
• MalfunctionJan 27, 2022High impedance; High impedance

  THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE LEAD WOULD NOT TEST OUT CORRECTLY AFTER CONNECTING TO THE IMPLANT. THERE WERE NO OTHER ISSUES AND NO CONTRIBUTING FACTORS WERE NOTED. MULTIPLE CONNECTIVITY AND IMPEDANCE TESTS WERE RUN AND BETWEEN EACH TEST THE WIRES WERE REMOVED AND RE-INSERTED CAREFULLY. IMPEDANCES FOR EVERY CONTACT SHOWED 40000 OHMS AND NEVER SHOWED A GOOD CONNECTION FOR ALL CONTACTS. A DIFFERENT LEAD WAS USED AND FUNCTIONED PERFECTLY. THERE WERE NO PATIENT ISSUES AND THE FINAL PLACEMENT WAS NOT AFFECTED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13368699 ↗
• MalfunctionDec 6, 2021High impedance; Connection Problem; High impedance; Connection Problem

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT LEAD WAS IMPLANTED IN THE PATIENT WHEN THEY WENT TO TEST CONNECTION TO THE BATTERY ONE CONTACT REMAINED UNCONNECTED AFTER RE INSERTING LEAD INTO BATTERY SEVERAL TIMES AND WIPING THE LEAD CLEAN. A HIGH IMPEDANCE OF 40000 WAS ON THE SAME MAKING IT UNUSABLE SO THEY OPENED ANOTHER LEAD, PLACED THAT IN THE PLACE, AND THE CONNECTION ISSUE WAS SOLVED. CONTACT REMAINED UNUSABLE WHEN LEAD WAS CONNECTED TO BATTERY. THE CONTACT HAD A HIGH IMPEDANCE AND NO MATTER HOW MANY TIMES IT WAS RE INSERTED INTO THE BATTERY THE CONTACT REMAINED UNUSABLE. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12935156 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). INFORMATION WAS REPORTED THAT THE NEUROMONITORING SIGNALS WENT BAD DURING THE PATIENT IMPLANT PROCEDURE. THE SURGEON TRIED PLACING THE PADDLE LEAD A FEW TIMES AND WAITED FOR THE SIGNALS TO GET BETTER. THEY DID NO SO HE DECLINED FOR THE PATIENT'S SAFELY TO ABORT THE CASE. THE SIGNALS RETURNED TO NORMAL AFTER THE PADDLE WAS REMOVED. THE PATIENT WAS SCHEDULED FOR A SPINAL CORD STIMULATOR (SCS) IMPLANT WITH THEIR LAMINECTOMY. THE LAMINECTOMY WAS COMPLETED AND WHEN THE SURGEON WENT TO PLACE THE PADDLE LEAD, THE PATIENT HAD ISSUES WITH NEUROMONITORING. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT, AND NO DEVICE WAS IMPLANTED IN THE PATIENT.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 10459864 ↗
• InjuryJul 6, 2020Difficult to Remove; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT IN 2019, WHILE THE LEAD WAS CONNECTED TO A COMPETITOR INS, THE PATIENT STARTED EXPERIENCING INADEQUATE BACK AND BUTTOCK PAIN RELIEF. THE PATIENT SAW THEIR PHYSICIAN, AND ON (B)(6) 2020, THE LEAD WAS REMOVED. DURING THE REMOVAL OF THE LEAD, IT WAS FOUND THAT SCAR TISSUE WAS ADHERED TO EACH OF THE CONTACTS ON THE LEAD. THE LEAD WAS SUCCESSFULLY REMOVED AND WAS SENT TO THE HOSPITAL PATHOLOGY DEPARTMENT, AND WOULD BE RETURNED TO THE MANUFACTURER AFTER PATHOLOGY WAS DONE WITH IT. DURING THE LEAD EXPLANT, ANOTHER LEAD WAS PLACED AND ATTACHED TO EXTENSIONS, WHICH WERE EXTERNALIZED AND CONNECTED TO A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: Scar Tissue; Therapeutic Effects, Unexpected

  MAUDE report 10235456 ↗
• MalfunctionMar 20, 2020Device Damaged Prior to Receipt by User; Insufficient Device Problem Information; Device Damaged Prior to Receipt by User; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE BOX LOOKED DAMAGE AND THE EDGE OF THE LEAD PACKAGING LOOKED DARK LIKE IT MAY HAVE BEEN WET AT SOME POINT. IT WAS NOTED THAT THE LEAD WAS PART OF THEIR TRUNK STOCK AND NOT FROM AN ACCOUNT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9862832 ↗
• InjurySep 24, 2019Break; Connection Problem; Break; Connection Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) CONCERNING PATIENT WITH IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON- MALIGNANT PAIN. IT WAS REPORTED HEALTHCARE PROVIDER (HCP) PLACED PADDLE LEAD FOR TRIAL 1 WEEK PRIOR. DURING GENERATOR IMPLANTATION ON THE DATE OF THE CALL, THE HCP WAS DISCONNECTING EXTENSIONS FROM THE PADDLE LEAD AND THE TRANSLUCENT COVER OVER THE CONNECTOR GOT STUCK WHILE HCP WAS ATTEMPTING TO DISCONNECT EXTENSION FROM PADDLE LEAD. THE HCP WAS UNABLE TO GET COVER OFF TO REMOVE EXTENSION, SO HE PULLED AND CAUSED THE END OF THE PADDLE LEAD TO FRACTURE. A NEW PADDLE LEAD WAS SIMPLY AND EASILY INSERTED INTO THE PATIENT AND THERE ARE NO ISSUES OTHER THAN THAT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9112306 ↗
• MalfunctionApr 24, 2019High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR ON (B)(6) 2019. IT WAS REPORTED THAT THE LEAD WAS PLACED AND AFTER DOING AN IMPEDANCE CHECK, ELECTRODES 1 AND 9 CAME BACK GREATER THAN 40,000 OHMS. AFTER DOING MULTIPLE IMPEDANCE CHECKS AND REPOSITIONING THE LEAD IN THE WIRELESS EXTERNAL NEUROSTIMULATOR, THE LEAD WAS REMOVED AND REPLACED. IMPEDANCE ON THE NEW LEAD WAS WITHIN NORMAL LIMITS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8546246 ↗
• InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED VIA THE MANUFACTURER REPRESENTATIVE THAT THE BOSTON SCIENTIFIC BATTERY ERODED THROUGH THE SKIN AND BECAME INFECTED. AFTER THE SYSTEM REMOVAL THE PATIENT WAS UNABLE TO MOVE THEIR LEGS AND WENT TO THE ER. IT WAS FOUND THAT THE PATIENT HAD AN EPIDURAL ABSCESS. NO DEVICE ISSUES REPORTED.

  Patient problems: Abscess; Paralysis

  MAUDE report 8289815 ↗
• MalfunctionJun 19, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THEY HAD PROBLEM WITH THE REMOTE AND HAD IT PROGRAMMED. THE PATIENT REPORTED THAT THEY HAVE NO IDEA ABOUT THE CIRCUMSTANCES THAT LED TO THE #4 LEAD GOING OUT. THE PATIENT STATED THAT THEY HAD SOME WEIRD ¿SHOCKISH¿ FEELING, NOT PLEASANT. THE PATIENT REPORTED THAT THEY HAD INTERFERENCE FROM THEIR CAR, HAD ISSUE WITH THE REMOTE BATTERY, AND SOMETIMES REMOTE DOESN¿T RESPOND TO TOUCH. THE PATIENT STATED THAT THEY WOULD GLADLY SPEAK ON BEHALF OF MANUFACTURER AND THE BENEFIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7613118 ↗
• MalfunctionOct 20, 2017Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT IMPLANTED FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT HAD A STAGE 1 BURIED LEAD FOR SPINAL CORD STIMULATION. THE IMPLANTABLE NEUROSTIMULATOR HAD NOT BEEN IMPLANTED YET. THE HEALTH CARE PROVIDER HAD CUT OR DAMAGED THE 0-7 LEAD AND ¿FOUR CONTACTS WERE OUT.¿ NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6966729 ↗
• InjuryJun 19, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR NON MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND SPASMING. THE PATIENT HAD A LEAD REVISION IN WHICH THE PADDLE WAS REMOVED AND REPLACED BY PERCUTANEOUS LEADS. AT THE TIME OF THE REVISION THE PHYSICIAN NOTED A "LUIF" BUILD UP AROUND THE PADDLE AND INDICATED THAT THIS MAY BE THE REASON FOR THE PAIN AND SPASMING THE PATIENT WAS EXPERIENCING. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Spasm(s); Pain

  MAUDE report 6650289 ↗

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