Specify® SureScan® 977C265Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000324223), received between Aug 10, 2022 and Aug 25, 2026 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during placement of the LEAD SPECIFY SURESCAN MRI 2X8, neuromonitoring reported loss of motor function on the left side of the patient¿s body without loss of somatosensory evoked potentials. Walking difficulty and numbness were reported. Anesthesia was reduced, the lead was removed, and the patient was closed. Following anesthesia reduction and lead removal, the patient was able to move the left leg and foot. The patient was alive with injury, and the issue was reported as ongoing. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Ambulation or Postural Difficulties; Numbness

  MAUDE report 50434157 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SPINAL CORD STIMULATOR IMPLANT PROCEDURE, A DURAL TEAR AND CEREBROSPINAL FLUID LEAK OCCURRED WHILE ACCESSING THE SPACE TO PLACE THE PADDLE LEAD WIRE. THE PROCEDURE WAS ABORTED, AND NO SPINAL CORD STIMULATOR IMPLANT WAS PLACED. THE PHYSICIAN PATCHED THE DURAL TEAR. THE ISSUE WAS RESOLVED. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cerebrospinal Fluid Leakage

  MAUDE report 22289802 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE (REP), HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE HCP OPENED THE PADDLE LEAD ON THE FIELD. HCP WAS USING A BRAIN SPATULA (NON-MEDTRONIC) AND STATED THEY WERE TRYING TO MOVE SCAR TISSUE FOR THE PADDLE LEAD TO FIT. WHEN DOING SO, A CSF LEAK WAS CREATED. HCP ATTEMPTED TO PLACE THE PADDLE LEAD, BUT THE LEAK WORSENED SO HCP REMOVED EVERYTHING AND ABORTED THE SURGERY. ON 2024-APR-08 THE REP REPORTED THAT THE BRAIN SPATULA STARTED THE CSF LEAK, DOCTOR ATTEMPTED TO PLACE PADDLE, AND DOCTOR SAID ¿IT MADE THE CSF LEAK WORSE¿. DOCTOR ABORTED THE CASE. DURASEAL WAS USED TO TREAT THE CSF LEAK. ON 2024-APR-10 THE REP PROVIDED HCP INFORMATION. THE ISSUE IS RESOLVED AT THIS TIME, AND THE LEAD WAS DISCARDED. WEIGHT WAS ASKED, BUT UNKNOWN.

  Patient problems: Cerebrospinal Fluid Leakage; Scar Tissue

  MAUDE report 19143646 ↗
• MalfunctionSep 25, 2023Break; Positioning Problem; Break; Positioning Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THE REP REPORTED THERE WAS AN "ABNORMALITY" WITH THE LEAD AND THEY REFERENCED THE PREVIOUS COMPLAINT RECORD ON THIS EVENT. THE SURGEON HAD ATTEMPTED TO PLACE THE LEAD AND NOTICED THE ELECTRODE WAS ABNORMAL. THE LEAD WAS EXPLANTED/NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808590 ↗
• InjurySep 1, 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. PATIENT HAD REPORTED ABDOMINAL PAIN AFTER THE IMPLANT, BEFORE THE STIMULATOR WAS TURNED ON. THE DOCTOR WHO PERFORMED THE SURGERY STATED THAT HE BELIEVED THAT IT WAS FROM POSITIONING ON THE TABLE. HOWEVER, AFTER SEVERAL DAYS IT WAS REPORTED THAT THE PATIENT WAS REPORTING THAT THEY COULDN'T PUT A SHIRT ON DUE TO THE PAIN. THEY WERE GETTING GOOD RELIEF IN THE BACK AND LEGS FROM THE STIMULATION BUT THE ABDOMINAL PAIN DIDN'T GO AWAY. REP HAD PATIENT TURN OFF STIMULATION. WHICH RESULTED IN NO CHANGE IN HIS SYMPTOMS. PATIENT SCHEDULED TO HAVE TRIAL LEAD REMOVED.

  Patient problems: Abdominal Pain

  MAUDE report 17670918 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLA NTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THERE WAS A LOSS OF MOTOR SIGNALS DURING IMPLANT. CASE ABORTED AFTER LEAD PLACED WHEN NEURO MONITORING SHOWED NO SIGNALS IN BILATERAL LEGS. LEAD REMOVED AND CASE STOPPED. PT ADMITTED TO HOSPITAL FOR FURTHER EVALUATION. PER PHYSICIAN, LEG MOVEMENT RETURNED SHORTLY AFTER PATIENT WAS IN RECOVERY. IT IS UNKNOWN IF THE ISSUE WAS RESOLVED. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 17370085 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT STATED THAT THEIR ABDOMINAL PAIN IMPROVED AFTER A COUPLE DAYS. SHE WAS BETTER THE DAY FOLLOWING SURGERY. SHE WAS IMPLANTED WITH THE STIMULATOR. SURGEON IS UNSURE OF THE CAUSE OF HER ABDOMINAL PAIN.

  Patient problems: Abdominal Cramps; Abdominal Pain; Discomfort; Pain

  MAUDE report 16533492 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED THAT PATIENT'S ABDOMINAL PAIN THAT STARTED IN POST OP WENT AWAY AFTER A COUPLE DAYS. SHE STATED THAT EACH DAY THE PAIN IMPROVED. SHE WAS IMPLANTED LAST WEEK. SURGEON IS UNSURE OF THE EXACT CAUSE OF THE ABDOMINAL PAIN.

  Patient problems: Abdominal Pain

  MAUDE report 16522829 ↗
• MalfunctionDec 5, 2022Break; Break

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915912 ↗
• MalfunctionAug 10, 2022Positioning Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. THE CALLER REPORTED THE SURGICAL LEAD WAS VEERING TO THE LEFT AND RIGHT AND UNABLE TO GET INTO THE CORRECT POSITION. THE PROCEDURE WAS SCRAPPED AND PATIENT WAS NOT IMPLANTED. PATIENT IS NOT REGISTERED (DOB (B)(6) 1967). NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15206534 ↗

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