Specify® SureScan® 977C165Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000324209), received between Oct 27, 2022 and Sep 17, 2026 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “High impedance” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (INS). The rep stated that the patient (pt) was implanted on Thursday and on Sunday morning, the pt showed up to the hospital in a paraplegic state and could not move their leg. The rep stated that they had to do emergency surgery and they removed the paddle lead but left the INS implanted. The rep also stated that there was a hematoma against the spinal cord, but they were able to remove the hematoma along with the paddle. The rep said that a few hours post op, the pt was moving their legs better than when they came in.

  Patient problems: Ambulation or Postural Difficulties; Hematoma; Paraplegia

  MAUDE report 50808530 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT PROCEDURE USING A LEAD, A LAMINOTOMY WAS PERFORMED AND A PADDLE LEAD WAS PLACED, AFTER WHICH NEUROMONITORING MOTOR TESTING SHOWED A DECREASED MOTOR RESPONSE. THE PADDLE LEAD WAS REMOVED AND MOTOR TESTING WAS REPEATED SEVERAL TIMES, WITH MINIMAL IMPROVEMENT AND THE MOTOR RESPONSE NOT RETURNING TO BASELINE. THE PROCEDURE WAS ABORTED DUE TO THE DECREASED MOTOR RESPONSE. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: Insufficient Information

  MAUDE report 25577921 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ATTEMPTED IMPLANTATION OF A SPINAL CORD STIMULATOR LEAD WAS ABORTED DURING THE PROCEDURE AFTER INTRAOPERATIVE NEUROMONITORING DETECTED DECREASED SOMATOSENSORY EVOKED POTENTIALS AND DECREASED MOTOR OUTPUT. WALKING DIFFICULTY, IMMOBILITY, AND LOSS OF BALANCE WERE REPORTED. THE PADDLE WAS REMOVED DURING THE PROCEDURE. THE ISSUE WAS REPORTED AS RESOLVED, AND THE PATIENT WAS REPORTED ALIVE WITH NO INJURY. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 25350607 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER ATTEMPTED TO IMPLANT A LEAD, BUT NEUROMONITORING IN THE CASE NOTIFIED THE SURGEON OF "LOSS OF MOTORS" WHEN THE PADDLE WAS PUT IN, SO THE CASE WAS ABORTED. PER THE PHYSICIAN, THE PATIENT WAS REGAINING SENSATION AND MOVEMENT AS OF (B)(6) 2026. THE CAUSE OF THE ISSUE WAS NOT DETERMINED, AND NO FURTHER ACTIONS WERE TAKEN, OR WERE PLANNED, TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 24268556 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PLACEMENT OF THE LEAD 977C165 SPECIFY SURESCAN MAGNETIC RESONANCE IMAGING (MRI) 5-6-5 PADDLE LEAD, THE PATIENT EXPERIENCED MULTIPLE ASYSTOLE EVENTS EACH TIME THE LEAD WAS INTRODUCED INTO THE EPIDURAL SPACE. THERE WERE PROLONGED PERIODS BEFORE RECOVERY OF NORMAL RHYTHM, AND NECESSARY INTERVENTION WAS REQUIRED DURING THE PROCEDURE. THE NEUROSURGEON AND ANESTHESIA TEAM ABORTED THE PROCEDURE. THE PATIENT UNDERWENT A LAMINECTOMY WITHOUT IMPLANTATION OF A SPINAL CORD STIMULATION SYSTEM AND WAS HOSPITALIZED OVERNIGHT IN THE INTENSIVE CARE UNIT FOR MONITORING. THE ISSUE WAS RESOLVED AND THE PATIENT WAS REPORTED TO BE STABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: Cardiac Arrest

  MAUDE report 23451384 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE LEAD 977C165, THE PATIENT EXPERIENCED NUMBNESS AND NERVE DAMAGE, LOSING FEELING IN THE ENTIRE RIGHT SIDE. AFTER THE LEAD WAS REMOVED, THE PATIENT GRADUALLY REGAINED FUNCTION AND FEELING IN THE RIGHT ANKLE, FOOT, AND EVENTUALLY THE LEG. WHEN THE LEAD WAS IMPLANTED AGAIN, THE SAME LOSS OF FEELING OCCURRED. ULTIMATELY, THE PATIENT WAS IMPLANTED WITH PERCUTANEOUS LEADS AND REGAINED FULL MOTOR FUNCTION AND FEELING IN THE RIGHT SIDE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE ISSUE WAS RESOLVED. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE. (B)(6) 2025. E1 (REP): ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT NERVE DAMAGE WAS NOT CONFIRMED AS PATIENT REGAINED ALL FEELING IN HIS BODY. THERE WAS NO PERMANENT NERVE DAMAGE.

  Patient problems: Numbness

  MAUDE report 21927076 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING THE LAMINATOR PORTION OF THE SURGERY, INSERTION OF THE PADDLE LEAD SIZER WAS ATTEMPTED BUT PATIENT LOST MOTOR FUNCTIONS IN LEGS AND TORSO. SEDATIONS WAS STOPPED AND ALL NARCOTICS REVERSED. SLOWLY THE PATIENT REGAINED USE OF LEGS AND TORSO. THE LEAD WAS NOT IMPLANTED AND WAS DISCARDED. PATIENT STATED IN RECOVERY THAT THEIR FEET WERE TINGLING. DUE TO THE LATE HOUR OF THE OPERATION AND THAT PHYSICAL THERAPIST WAS AVAILABLE TO EVALUATE THE PATIENT'S ABILITY TO WALK, THE PATIENT WAS KEPT OVERNIGHT IN THE HOSPITAL FOR OBSERVATION. THE FOLLOWING DAY PATIENT REPORTED THE ABILITY TO MOVE EXTREMITIES AGAIN BUT REPORTED UNEXPLAINED RIB PAIN. THE ISSUE IS ONGOING, AND ANOTHER ATTEMPT AT IMPLANT IS PLANNED. THE REP NOTED THEY WOULD SUBMIT ANY NEW INFORMATION THAT BECOMES AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain; Paresthesia

  MAUDE report 21275218 ↗
• MalfunctionDec 12, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT A LEAD 977C165 SPECIFY SURESCAN MRI 5-6-5 EXPERIENCED AN IMPEDANCE ISSUE CHARACTERIZED BY LOW IMPEDANCE OR A SHORT DURING THE IMPLANT PROCEDURE. THE CONNECTION WAS SHORTED, AND WHEN THE LEAD WAS PLACED IN BOTH PORTS, IT SHOWED THE SAME SHORTED ELECTRODES. TROUBLESHOOTING WAS PERFORMED, WHICH INCLUDED CLEANING THE LEADS AND ATTEMPTING PLACEMENT SEVERAL TIMES. THE PRODUCT WAS NOT IMPLANTED AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913877 ↗
• MalfunctionNov 4, 2024Unintended Collision; Energy Output Problem; Unintended Collision; Energy Output Problem

  INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT REPORTED THAT SHE FELL ON (B)(6) 2024. AFTER THAT SHE FELT UNCOMFORTABLE STIMULATION REQUIRING HER TO ADJUST HER SETTINGS. IMPEDANCES ARE NORMAL AND PARESTHESIA COVERAGE IS THE SAME. RECALIBRATED THRESHOLDS FOR DTM. PATIENT PLEASED. THE ISSUE WAS RESOLVED.

  Patient problems: Discomfort

  MAUDE report 20600413 ↗
• MalfunctionSep 9, 2024High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE LEAD WAS FOUND TO HAVE MULTIPLE CONTACTS OVER 40000 OHMS. THE LEAD WAS TRIED IN THE IMPLANT AND TWO DIFFERENT WIRELESS EXTERNAL NEUROSTIMULATORS AND ALL HAD THE SAME RESULT. THERE WERE NO OTHER STIMULATION ISSUES. THE CAUSE WAS NOT KNOWN AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170130 ↗
• MalfunctionMay 18, 2023Break; High impedance; Connection Problem; Adverse Event Without Identified Device or Use Problem; Break; High impedance; Connection 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 THERE WAS A BENT CONTACT ON THE PADDLE LEAD. CONTACT 11 WAS DAMAGED AND WOULD NOT CONNECT TO THE INS PORT OR WIRELESS EXTERNAL NEUROSTIMULATOR (WENS) PORT. THE PRODUCT DAMAGE WAS CAUSED OR DISCOVERED DURING SURGERY. THERE WERE HIGH IMPEDANCES GREATER THAN 40,000 OHMS ON THE DAY OF SURGERY. THE CAUSE WAS UNKNOWN. THE LEAD WAS NOT USED, AND IS TO BE RETURNED FOR ANALYSIS. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955124 ↗
• InjuryMar 13, 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 POST-OP, THE PATIENT WAS HAVING NEW PAIN (UNRELATED TO BASELINE). THEY ALSO HAD WALKING DIFFICULTY/IMMOBILITY/LOSS OF BALANCE/UNABLE TO GET OUT OF BED, AND BLADDER INCONTINENCES. THE PATIENT WAS SENT FROM THE SURGERY CENTER TO THE HOSPITAL FOR FURTHER TESTING/TREATMENT.

  Patient problems: Ambulation or Postural Difficulties; Pain; Urinary Retention

  MAUDE report 16533767 ↗
• InjuryOct 27, 2022Adverse 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 TO BE IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. THE REP SAID HCP TORE THE DURA DURING IMPLANT PROCEDURE, THUS THE HCP HAD TO ABANDON THE PROCEDURE. HCP USED DURA PATCH TO ADDRESS THE ISSUE. TROUBLESHOOTING WAS NOT REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP ON 2022-SEP-29. THE REP COULD NOT CLARIFY IF THE DURAL MATTER WAS TORN OR IF THERE WAS BLEEDING ASSOCIATED WITH THE TEAR. THE CAUSE IS UNKNOWN. THE PATIENT IS NOW DOING FINE. WEIGHT WAS NOT REPORTED.

  Patient problems: Insufficient Information; Spinal Cord Injury

  MAUDE report 15686176 ↗

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