Vectris™ SureScan® 977A275 (UDI 00643169109384)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169109384), received between Dec 14, 2016 and Mar 23, 2021 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (4 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.

• MalfunctionMar 23, 2021Break; Break

  CAUSE OF LEAD DAMAGE UNKNOWN. THE PHYSICIAN NOTED IT WAS FRAYED AT THE TIP SO REP OPENED ANOTHER ONE AND RETURNED IT. REP CONFIRMED THE DATE WAS 2020-DEC-11. THE HCP PUT THE LEAD IN THE NEEDLE, BROUGHT IT BACK OUT, TRIED RUNNING IT, COULDN'T GET IT. RAN IT OUT OF NEEDLE COUPLE OF TIMES, CHANGED STYLET AND HE NOTICED THAT PART OF THE END WAS FRAYED. LEAD WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11555254 ↗
• InjuryDec 13, 2020Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area; Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THE CUSTOMER DID NOT RETURN THE DEVICE AND IT WAS DISPOSED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THE LEAD WAS REVISED ON 12/17 AND THE PATIENT HAD COVERAGE FOR RIGHT ARM AND HAND BUT PATIENT HAD A LEFT FOOT DEFICIT. THEY HAD POST OP ON 12/22 BUT REPORTED WEAKNESS THAT WAS NEW AFTER THE SURGERY. THE PATIENT AND MEDICAL DOCTOR REPORTED POSSIBLE CAUSE AS SURGICAL POSITIONING AS BOTH HEAD AND SPINE MRI WERE UNEVENTFUL.

  Patient problems: Muscle Weakness/Atrophy; Undesired Nerve Stimulation

  MAUDE report 10997333 ↗
• InjuryNov 17, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THE DEVICE WAS DISCARDED.

  Patient problems: Pain

  MAUDE report 10852925 ↗
• InjuryNov 13, 2017Failure to Deliver Energy; High impedance; Failure to Deliver Energy; High impedance

  ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE. IT WAS REPORTED THAT THE CAUSE WAS NOT DETERMINED, THE PATIENT REPORTED THAT THEY DIDN'T FALL OR ANYTHING. THEY TRIED TO REPROGRAM THE PATIENT BUT WERE UNABLE TO FEEL ANY STIMULATION. THE ISSUE WASN'T RESOLVED AND THE REPRESENTATIVE TOLD THEM THAT THEY NEEDED TO HAVE A LEAD REVISION BUT THE PATIENT DIDN'T WANT TO DO ANYTHING RIGHT NOW. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Therapeutic Effects, Unexpected; Therapeutic Response, Decreased

  MAUDE report 7026359 ↗
• MalfunctionAug 15, 2017Difficult to Insert; Positioning Problem; Difficult to Insert; Positioning Problem

  THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT WAS HAVING THE FULL SYSTEM REPLACED DUE TO NEEDING AN MRI SO THEY WERE IMPLANTING A NEW MRI SAFE IMPLANT AND LEAD. THE HEALTHCARE PROFESSIONAL (HCP) REMOVED THE OLD LEAD WITH AN ANGIOCATH TO TRY TO MAINTAIN THE ORIGINAL LEAD TRACK. THE LEAD WAS REMOVED AND THE NEW LEAD INSERTED INTO THE ANGIOCATH AND IT APPEARED TO BE GOING EASY INTO THE EPIDURAL SPACE. THEN THE LEAD APPEARED TO BE GOING ANTERIOR AND THE HCP REMOVED THE STYLET MULTIPLE TIMES AND USED ALL THE DIFFERENT STYLETS IN THE KIT. THE HCP INDICATED IT SEEMED LIKE THE STYLET WAS CATCHING ON THE ELECTRODES ON THE DISTAL END AND THE STYLET WOULD ONLY ADVANCE TO WITHIN 1-2 INCHES FROM THE DISTAL END OF THE LEAD. FLOURO WAS SHOWING SOME CURVING BUT NOTHING REMARKABLE. THE HCP OPENED A NEW LEAD AND DIDN¿T HAVE ISSUES BUT HAD TO USE THE NEEDLE TO ADVANCE THE LEAD INSTEAD OF THE ANGIOCATH. NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6793969 ↗
• MalfunctionJul 11, 2017Break; Difficult to Remove; Break; Difficult to Remove

  INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE FROM A HEALTH CARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THERE WAS A LEAD MALFUNCTION THAT OCCURRED INTRA-OPERATIVELY. THE LEAD WAS IMPLANTED PARTIALLY, BUT WHEN THEY TRIED TO REMOVE THE STYLET, IT WOULD NOT COME OUT. THEY TRIED TO GENTLY REMOVE THE STYLET FOR SEVERAL MINUTES AND ULTIMATELY THE STEERING CAP POPPED UP. FORCEPS WERE USED TO TRY TO GRAB THE STYLET AND REMOVE, BUT COULD NOT. THE LEAD WAS REMOVED FROM THE EPIDURAL SPACE, AND A NEW LEAD WAS USED. THE STYLET COULD NOT BE REMOVED FROM THE LEAD, AND THE MANUFACTURER REPRESENTATIVE WATCHED THE HEALTH CARE PROVIDERS TRY FOR ALMOST 10 MINUTES. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6702502 ↗
• MalfunctionJul 10, 2017Device Damaged Prior to Receipt by User; Material Deformation; Device Damaged Prior to Receipt by User; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS). IT WAS REPORTED THAT A LEAD WAS FOUND TO BE BENT DURING PRE-SURGICAL PREPARATION. THE LEAD WAS OPENED AND A SURGICAL SCRUB NOTICED THAT THE LEAD WAS BENT DURING PACKAGE INVENTORY. THE PATIENT WAS ON THE TABLE UNDERGOING SURGICAL PREPARATION. THE LEAD KIT WAS REMOVED FROM THE STERILE FIELD AND REPLACED WITH A BACK-UP KIT. THE SURGERY HAD NOT STARTED AT THE TIME OF THE FINDING. IT WAS NOTED THAT THE PACKAGE WAS INTACT WITH NO DAMAGE WHEN OPENED. THE LEAD WAS OPENED AND FOUND TO BE BENT IN THE PACKAGE. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6696974 ↗
• MalfunctionJun 20, 2017Difficult to Insert; Device Operates Differently Than Expected; Difficult to Insert; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED VIA A HEALTHCARE PROFESSIONAL FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL FOR PAIN THERAPY. WHILE IMPLANTING THE ELECTRODE, THE DOCTOR STATED THAT IT WAS HARD TO PASS THROUGH AND FELT IT WAS TOO NARROW. THE PATIENT DIDN'T REPORT ANY ISSUES. THERE WERE NO FACTORS NOTED THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE DOCTOR COULDN'T FIGURE OUT WHAT WAS WRONG WITH EITHER THE CANNULA OR THE ELECTRODE. THE DOCTOR TRIED TO PASS IT THROUGH UNTIL HE MADE IT. IT WAS ALSO REPORTED THAT, EVEN THOUGH THE CANNULA PRESENTED A PROBLEM WHILE INTRODUCING THE ELECTRODE, THE DOCTOR WAS ABLE TO PASS IT THROUGH. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT COMPLICATION WAS ASSOCIATED WITH THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6654320 ↗
• MalfunctionJan 3, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  THE MANUFACTURER REPRESENTATIVE REPORTED THAT X-RAY SHOWS THAT THE LEAD HAD PULLED DOWN AND INTO THE ¿GUTER¿ OR LATERAL AREA OF THE EPIDURAL SPACE. IT WAS REPORTED THAT THE PATIENT STARTED TO HAVE STIMULATION IN SIDE AND MADE TWITCHING IN SIDE. IMPEDANCE WAS CHECKED AND X-RAY DONE. THE REPRESENTATIVE WAS ABLE TO TURN OFF THE LEAD THAT HAD MOVED AND GET ALL THE AREAS OF PAIN COVERED WITH ON LEAD THAT STILL WAS IN PLACE. THE PATIENT WAS REPORTED HAPPY AFTER REPROGRAMMING.

  Patient problems: Twitching

  MAUDE report 6219804 ↗
• MalfunctionDec 14, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT HAD MIGRATED CERVICAL LEADS AND THE LEADS WERE EXPLANTED. IT WAS REPORTED THAT THE FULL SYSTEM WAS EXPLANTED AND A NEW SYSTEM IMPLANTED. NO SYMPTOM WAS REPORTED. THE PATIENT INDICATION FOR USE IS NON-MALIGNANT PAIN AND COMPLEX REG PAIN SYNDROME TYPE I.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6173978 ↗

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