Vectris SureScanRecalls & reported problems across all models

We found 11 models of Vectris SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 267 adverse event reports in the FDA's MAUDE database, received between Nov 23, 2016 and Sep 23, 2026 — classified as 1 death, 74 injuries, 192 malfunctions.

The most frequently reported specific device problem is “Break” (80 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 Vectris SureScan problems

Vectris SureScan models

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

• Vectris™ SureScan® 977A260

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 death89 reports
• Vectris™ SureScan® 977A260

  Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
  71 reports
• Vectris™ SureScan® 977A260

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  61 reports
• Vectris™ SureScan® 977A275

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  13 reports
• Vectris™ SureScan® 977A275

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  10 reports
• Vectris™ SureScan® 977A275

  Stimulator, spinal-cord, totally implanted for pain relief
  8 reports
• Vectris™ SureScan® 977A290

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  7 reports
• Vectris™ SureScan® 977A290

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  3 reports
• Vectris™ SureScan® 977A160

  Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
  2 reports
• Vectris™ SureScan® 977A290

  Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
  2 reports
• Vectris™ SureScan® 977A160

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 report

Recent Vectris SureScan adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Positioning Problem

  It was reported that during an attempted implant procedure of two LEAD 977A260 5MM COMPACT 1X8 MRI leads, the patient underwent multiple unsuccessful attempts to place electrodes. The leads could not be maintained in a dorsal position, and two wet taps occurred during the procedure. The implant procedure was aborted, neither lead was implanted, and the leads were removed. The patient had a midline incision over the upper lumbar and lower thoracic area and was referred to neurosurgery for paddle implant placement. The issue was resolved. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 50868198 ↗
• InjurySep 23, 2026Positioning Problem

  It was reported that during an attempted implant procedure of two LEAD 977A260 5MM COMPACT 1X8 MRI leads, the patient underwent multiple unsuccessful attempts to place electrodes. The leads could not be maintained in a dorsal position, and two wet taps occurred during the procedure. The implant procedure was aborted, neither lead was implanted, and the leads were removed. The patient had a midline incision over the upper lumbar and lower thoracic area and was referred to neurosurgery for paddle implant placement. The issue was resolved. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 50868195 ↗
• InjuryAug 14, 2026Unintended Collision; Overheating of Device

  Information was received from a patient (pt) with an implanted neurostimulator (INS). It was reported that they switched to a compet itor's product in 2020, but they were still using the Medtronic leads and so they could not have a MRI. Pt said that the device was causing them pain, so they were told to turn the device off. Pt said that they had burning sensations from their left knee up to their thigh. Pt said that they were told to find another doctor to have the device removed. Pt said that they hadn't turned the competitor's device off until recently due to having extreme pain. Pt said that they told the competitor's manufacturer representative (rep) that the implantable neurostimulator (INS) needed to be removed. Pt said that if it came down to it, they would find someone to open up their back and remove the device and then they would end up in the ER. Pt said that they could only sleep 3-4 hours a day. Pt said that they had a fall in October 2024, but they had no problems until about a month and a half ago. Agent redirected Pt to HCP to further address.

  Patient problems: Burning Sensation; Pain; Sleep Dysfunction

  MAUDE report 50260830 ↗
• InjuryAug 14, 2026Unintended Collision; Overheating of Device

  Information was received from a patient (pt) with an implanted neurostimulator (INS). It was reported that they switched to a compet itor's product in 2020, but they were still using the Medtronic leads and so they could not have a MRI. Pt said that the device was causing them pain, so they were told to turn the device off. Pt said that they had burning sensations from their left knee up to their thigh. Pt said that they were told to find another doctor to have the device removed. Pt said that they hadn't turned the competitor's device off until recently due to having extreme pain. Pt said that they told the competitor's manufacturer representative (rep) that the implantable neurostimulator (INS) needed to be removed. Pt said that if it came down to it, they would find someone to open up their back and remove the device and then they would end up in the ER. Pt said that they could only sleep 3-4 hours a day. Pt said that they had a fall in October 2024, but they had no problems until about a month and a half ago. Agent redirected Pt to HCP to further address.

  Patient problems: Burning Sensation; Pain; Sleep Dysfunction

  MAUDE report 50260826 ↗
• MalfunctionJun 8, 2026Break; High impedance

  IT WAS REPORTED THAT THE PHYSICIAN VISUALIZED A POSSIBLE ISSUE IN THE LEAD WHERE THE COMPETITOR'S IMPLANTABLE PULSE GENERATOR SET SCREW APPEARED TO COMPROMISE THE LEAD BODY. HIGH LEAD IMPEDANCE WAS OBSERVED ON THE DAY OF SURGERY, AND IMPEDANCE TESTING WAS PERFORMED WITH REPORTED VALUES OF 23531, 29627, 34217, 28285, 25531, 21901, 20531, AND 33422; CONTACTS 0¿7 WERE REPORTED TO HAVE GOOD IMPEDANCE VALUES. IT WAS REPORTED THAT THE LEAD WAS SEATED ALL THE WAY IN THE HEADER WITH GREEN X¿S EXCEPT FOR CONTACT 13, AND THAT THE PATIENT HAD BEEN SWITCHED TO THE COMPETITOR 12-CONTACT GENERATOR WITH A LARGER HEADER, AFTER WHICH THE SET SCREW WAS TIGHTENED DOWN ONTO THE BODY OF THE LEAD. TROUBLESHOOTING WAS PERFORMED, AND IT WAS REPORTED THAT BILATERAL AND ISOLATED RIGHT-SIDED COVERAGE WAS ACHIEVED AND CLOSED LOOP SPINAL CORD STIMULATION WAS SET UP. THE ISSUE WAS REPORTED TO BE ONGOING AND UNRESOLVED. NO PATIENT INJURY OR ADVERSE OUTCOME WAS REPORTED. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429625 ↗
• MalfunctionMay 1, 2026Break; Difficult to Insert

  THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT SURGEON WAS NOT ABLE TO REINSERT THE STYLET ONCE IT WAS REMOVED. REP SAID SURGEON HAD TO USE ANOTHER LEAD. REP TO SEND LEAD BACK FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056109 ↗
• MalfunctionApr 9, 2026Unsealed Device Packaging; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT, PRIOR TO USE, THE IMPLANTABLE LEAD WAS FOUND WITH CRACKED PACKAGING AND THE DEVICE WAS NEVER IMPLANTED. DUE TO QUESTIONABLE STERILITY OF THE PRODUCT INSIDE, THEY DID NOT USE THE PRODUCT. THE LEAD COMPONENTS INSIDE THE PACKAGING WERE DISCARDED BY THE CUSTOMER, AND THE CRACKED PACKAGING WAS RETAINED FOR RETURN. THERE WAS NO PATIENT INVOLVED. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831952 ↗
• MalfunctionMar 9, 2026Difficult to Insert; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER INITIAL PLACEMENT OF THE LEAD, THE PHYSICIAN ATTEMPTED TO REINSERT THE STYLET TO ASCEND THE LEAD TIP HIGHER AND DISCOVERED A BLOCKAGE AT THE DISTAL END OF THE LEAD, WHICH WAS POTENTIALLY A BLOOD CLOT. MULTIPLE ATTEMPTS WERE MADE TO THREAD THE STYLET, BUT THESE WERE UNSUCCESSFUL. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546270 ↗
• MalfunctionJan 26, 2026Impedance Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE DOCTOR WAS PLACING THORACIC PERC LEADS AND THE ENTIRE LEAD WAS LIT UP RED WHEN CHECKING THE CONNECTION IN THE WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). THIS WAS A DEVICE ISSUE WHEN CONNECTING A NEW LEAD TO A NEW WENS, ALL CONNECTIONS WERE RED. THE PATIENT DIDN¿T EXPERIENCE AN ISSUE. THE ISSUE WAS A LEAD ISSUE OUT OF THE BOX. AFTER TESTING THE LEAD CONNECTION IN THE WENS, THE LEAD WAS MOVED TO THE OTHER SIDE OF THE WENS (0-7 TO 8-15) AND THE LEAD CONNECTIONS WERE ALL STILL RED. REP OPENED A NEW LEAD AND THEIR WERE NO ISSUES AT ALL. ALL CONNECTIONS WERE GOOD ON THE SAME WENS. THE CAUSE WAS NOT KNOWN. THE ISSUE WAS RESOLVED. THE DEVICE WAS IN REP'S POSSESSION. WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183682 ↗
• MalfunctionJan 9, 2026Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT DURING A PATIENT'S CASE, THE PROCEDURE HAD TO BE ABORTED DUE TO THE INABILITY TO GAIN ACCESS INTO THE EPIDURAL SPACE. DESPITE MULTIPLE ATTEMPTS TO ACCESS, THIS WAS UNSUCCESSFUL AND THE DECISION WAS MADE TO STOP THE PROCEDURE FOR PATIENT SAFETY. AS A RESULT, ONE LEAD WAS OPENED AND USED DURING THE ATTEMPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24024190 ↗
• MalfunctionDec 30, 2025High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT'S IMPLANT PROCEDURE. IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES. MANUFACTURER REPRESENTATIVE (REP) CHECKED CONNECTIONS WITH LEAD IN BOTH CHANNELS (0-7 AND 8-15) OF EXTERNAL NEUROSTIMULATOR AND THE SAME ELECTRODE SHOWED THE HIGH IMPEDANCE VALUE ON ELECTRODE 4 OR 12 DEPENDING ON THE CHANNEL. THE LEAD WAS THEN PLACED INTO THE NEUROSTIMULATOR AND CONTINUED TO SHOW HIGH IMPEDANCE VALUE ON ONE ELECTRODE SO THE PHYSICIAN REQUESTED A NEW LEAD. CAUSE IS NOT KNOWN, BUT THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923544 ↗
• MalfunctionDec 9, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER ATTEMPTING TO PLACE THE LEAD 977A260 5MM COMPACT 1X8 MAGNETIC RESONANCE IMAGING (MRI) AND REMOVING IT FROM THE STYLET, THE LEAD WAS FOUND TO BE FRACTURED, DAMAGED, AND BROKEN. THE DEVICE WAS NEVER IMPLANTED. THE ISSUE WAS RESOLVED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756437 ↗
• InjuryNov 24, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). REP REPORTS THERE WAS AN ANCHOR ISSUE. REP REPORTS A LEAD MIGRATION OR DISLODGEMENT OCCURRED. PRODUCTS DID NOT MIGRATE AROUND OR ENTANGLE INTERNAL ORGANS. NO STIMULATION ISSUES WERE REPORTED AS A RESULT OF THIS ISSUE. LEADS WERE EXPLANTED. REP REPORTS THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23636265 ↗
• InjuryNov 24, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). REP REPORTS THERE WAS AN ANCHOR ISSUE. REP REPORTS A LEAD MIGRATION OR DISLODGEMENT OCCURRED. PRODUCTS DID NOT MIGRATE AROUND OR ENTANGLE INTERNAL ORGANS. NO STIMULATION ISSUES WERE REPORTED AS A RESULT OF THIS ISSUE. LEADS WERE EXPLANTED. REP REPORTS THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23636248 ↗
• MalfunctionNov 12, 2025High impedance; Adverse Event Without Identified Device or Use Problem; High impedance; Adverse Event Without Identified Device or Use Problem

  INS IS NEW AND IMPLANTED NOTHING WAS WRONG WITH THAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533996 ↗

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