Specify SureScanRecalls & reported problems across all models

We found 2 models of Specify SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2022 and Sep 17, 2026 — classified as 16 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 Specify SureScan problems

Specify SureScan models

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

• Specify® SureScan® 977C165

  Stimulator, spinal-cord, totally implanted for pain relief
  13 reports
• Specify® SureScan® 977C265

  Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
  10 reports

Recent Specify SureScan adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 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 ↗
• 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 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 ↗
• 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 ↗

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