Vectris™ 977D260 (UDI 00763000006570)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00763000006570), received between Jul 23, 2018 and Jan 30, 2024 — classified as 8 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  ON 2021-MAY-03, INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPL ANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE TRIAL LEAD WAS OPENED AND THE PHYSICIAN ATTEMPTED TO PLACE THE LEAD. HOWEVER, THE LEAD LOOKED TO BE A LITTLE DISTORTED OR BENT. THE DOCTOR REMOVED THE STYLET TO SEE IF THE STYLET WAS BENT BUT IT WAS NOT. HE PLACED THE STYLET BACK INTO THE LEAD AND AGAIN THE LEAD LOOKED DISTORTED. THERE SEEMED TO BE SOME SLIGHT RESISTANCE IN INSERTING THE LEAD BUT THERE WAS NO ¿FORCING¿ OF THE LEAD OR AGGRESSIVE TORKING OF THE LEAD. THE PHYSICIAN REQUESTED A NEW LEAD. THERE WERE NO ISSUES WITH THE NEW LEAD. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. ON 2021-MAY-14, ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP AND IT WAS REPORTED THAT THE CAUSE OF THE ISSUE WITH THE LEAD WAS NOT DETERMINED. THE LEAD WAS SENT FOR ANALYSIS. ON 2021-05-13, ADDITIONAL INFORMATION RECEIVED. REP REPORTED LEAD WAS WAVY, UNABLE TO GUIDE LEAD INTO PLACE. DIFFICULTY STEERING. RECOVERED WITHOUT SEQUALAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607118 ↗
• MalfunctionJun 29, 2022Break; Failure to Deliver Energy; Migration or Expulsion of Device; Energy Output Problem; Break; Failure to Deliver Energy; Migration or Expulsion of Device; Energy Output Problem

  INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. PT REPORTS ONE OF THE LEADS GOING INTO SPINAL CORD BROKE ON THE FIRST NIGHT OF THE TRIAL. PT STATES BECAUSE OF THE LEAD BREAKING THERE WAS NO DATA IF THE SCS DEVICE WOULD HELP OR NOT. PATIENT WAS IMPLANTED WITH A TRIAL LEAD IN HIS THORACIC SPINE AND ON DAY 2 OF THE TRIAL REPORTED THAT HE FELT LIKE IT WAS NO LONGER WORKING. THE REMOTE ALSO STATED UNABLE TO INCREASE DESIRED SETTINGS. SO A REP MET UP WITH THE PATIENT TO EVALUATE AND NOTICED THAT THE LEAD WAS BROKEN NEAR THE WENS UNDER THE TAPE. THE REP DISCONNECTED AND RECONNECTED THE LEAD WHEN SHE NOTICED THE WIRE WAS BROKEN. THE PATIENT STATED HE NEVER FELT ANY PULLING OR TUGGING OF THE LEAD DURING MOVEMENT. CAUSE UNKNOWN. THE PATIENT HAS A CERVICAL TRIAL STILL IN PROGRESS. THE DOCTOR WANTS TO KEEP THE CERVICAL LEAD IN PLACE UNTIL TUESDAY AND THEN WILL REMOVE BOTH LEADS AND SEND TO MEDTRONIC ON (B)(6) 2022.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14853353 ↗
• MalfunctionApr 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WITH A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT DURING 2 LEAD TRIAL, AFTER LEAD WAS PLACED IN EPIDURAL SPACE AND IN WENS. CONNECTIVITY WAS CHECKED, CONNECTION WAS NOT MEET. DOCTOR WIPED OFF LEAD AND REPLACED IN WENS 0-7, NO CONNECTIVITY. CHANGED LEAD TO 8-15, NO CONNECTIVITY. THE CAUSE WAS UNKNOWN. REMOVED THIS LEAD AND USED DIFFERENT TRIAL LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14084392 ↗
• MalfunctionMar 24, 2022Positioning Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT HCP WAS PLACING LEADS FOR TRIAL AND WASN¿T ABLE TO ADVANCE LEADS BEYOND T9 LEVEL. ONCE TO THAT LEVEL PATIENT COMPLAINED OF PAIN IN BACK AREA. HCP REMOVED ONE LEAD AND PULLED DOWN THE OTHER LEAD TILL PT SAID NO PAIN WAS IN BACK. AFTER BANDAGING LEAD IN PLACE AND PROGRAMMING PATIENT THE PATIENT LEFT HOSPITAL. SHE WENT OUT TO CAR AND WHEN REACHED FOR SEATBELT GOT SHARP PAIN IN RIB AREA. SHE RETURNED AND LEAD WAS REMOVED. PAIN WENT AWAY

  Patient problems: Pain

  MAUDE report 13890401 ↗
• MalfunctionMar 23, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (PATIENT, MANUFACTURER REPRESENTATIVE (REP), HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT REPORTED NOT BEING ABLE TO INCREASE THE TRIAL INS SETTINGS WITH HER TRIAL REMOTE CONTROL. REP MADE AN APPT TO SEE THE PT WITH THEIR HEALTHCARE PROVIDER (HCP) AT THE CLINIC AND PLANNED TO CHANGE OUT THE TRIAL PT CONTROLLER ON (B)(6) 2022. REP COMPLETED FURTHER TROUBLE SHOOTING WHEN THEY MET WITH THE PT IN CLINIC AND IT WAS DETERMINED THAT THE EQUIPMENT WAS FUNCTIONING PROPERLY BUT FOR ONLY THE LEFT LEAD AND NOT THE RIGHT LEAD. HCP ORDERED AN X-RAY AND IT WAS DETERMINED THAT THE RIGHT LEAD HAD MIGRATED OUT OF THE POSITION ACHIEVED ON (B)(6) 2022. THE LEAD HAD BEEN PLACED PERIPHERALLY UNDER THE SKIN IN THE LATERAL MID BACK ON THE RIGHT SIDE SUBCUTANEOUS. THE LEAD MIGRATED ALL THE WAY OUT OF POSITION AND ALL IMPEDANCES WERE OUT OF RANGE 8-15 LEAD. THE EXTERNAL NEUROSTIMULATOR (ENS) AND PT CONTROLLER WOULD ONLY WORK ON THE LEFT SIDE LEAD. REP REPROGRAMMED THE ENS FOR ONLY THE ONE LEAD AND HCP CONTINUED THE TRIAL BUT ONLY ON THE PT¿S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13864548 ↗
• InjuryMar 14, 2022Adverse 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 A TRIAL LEAD ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT HAD PAIN IN HIS KIDNEYS AROUND MIDNIGHT (B)(6) 2022, SO HE TURNED OFF THE STIMULATOR AND THE PAIN CONTINUED. HE WENT TO EMERGENCY ROOM AND THEY REMOVED THE TRIAL LEADS. THEY DID AN MRI AND FOUND A BLOOD CLOT (PER PATIENT) SO THEY PLACED A DRAIN IN THEIR SPINE TO RELIEVE PRESSURE OF CLOT. TRIAL LEADS REMOVED AND DRAINS PLACED. THERE WERE NO KNOWN EXTERNAL/ENVIRONMENTAL/PATIENT FACTORS NOTED TO BE CONTRIBUTING TO THE ISSUE.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 13759852 ↗
• InjuryFeb 25, 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 IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A DOUBLE LEAD PLACEMENT FOR SCS TRIAL. WHEN THE PATIENT ARRIVED IN THE PACU DEPARTMENT, SHE REPORTED AN INCREASE IN LEFT LEG AND BUTTOCK PAIN. IMPEDANCES AND CONNECTIVITY WERE CHECKED AND AFTER EVALUATION THE PHYSICIAN DECIDED TO REMOVE THE LEADS TO EVALUATE IF THE PAIN RESOLVED OR DECREASED. AFTER THE LEADS WERE REMOVED, THE PATIENT WAS SENT FOR FURTHER EVALUATION WHERE IT WAS DISCOVERED THAT THE PATIENT HAD RECEIVED A TORN HAMSTRING UPON TRANSFERS IN THE PROCEDURE AREA. THE PHYSICIAN REPORTS THAT THE CURRENT CONCERN WILL NEED TO BE RESOLVED PRIOR TO THE PATIENT UNDERGOING ANOTHER TRIAL FOR SCS.

  Patient problems: Pain

  MAUDE report 13603492 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Pain; Unspecified Nervous System Problem

  MAUDE report 13524809 ↗
• MalfunctionJan 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  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  THE TRIAL LEAD WAS IMPLANTED AND PUT IN THE WIRELESS NEURO STIM AND IT KEPT REGISTERING ¿S FOR 11-15 ELECTRODES. THE LEAD WAS TAKEN OUT AND WIPED AND SET IN THE WENS BUT IT STILL READ FOR THE 8-15 SIDE. IT WAS TRIED ON THE 0-7 SIDE WITH THE SAME RESULT. THE LEAD WAS REMOVED FROM THE NEEDLE AND A NEW LEAD WAS GIVEN TO THE HEALTHCARE PROVIDER. IT WAS NOTED THE LEAD WAS NEVER IMPLANTED. THE ISSUE WAS RESOLVED AT THE TIME OF REPORT.  NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314919 ↗
• MalfunctionJan 7, 2022Break; High impedance; Insufficient Device Problem Information; Break; High impedance; Insufficient Device Problem Information

  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 DURING A TRIAL PROCEDURE ON (B)(6) 2022, A NEW TRIAL LEAD WAS TAKEN OUT OF PACKAGING. THE HEALTHCARE PROVIDER (HCP) NOTICED THAT THE LEAD DID NOT LOOK RIGHT BUT THEY DECIDED TO TRY THE LEAD ANYWAY. AFTER ADVANCING THE LEAD INTO THE EPIDURAL SPACE THEY CHECKED THE IMPEDANCES AND ALL CONNECTIVITY CHECK WAS RED X. ALL ELECTRODE IMPEDANCES WERE >40K. THEY TRIED THE SAME LEAD IN THE OTHER SLOT OF THE WENS WITH THE SAME HIGH IMPEDANCE RESULTS. THE OTHER LEAD THEY WERE WORKING WITH WAS ALSO TRIED IN BOTH SLOTS AND HAD NORMAL IMPEDANCES. IT WAS NOTED THAT THE INTERNAL WIRING OF THE LEAD IN QUESTION APPEARED TO HAVE BROKEN WIRING INTERNALLY. THEY REPLACED THE LEAD IN QUESTION WITH A NEW LEAD AND THE IMPEDANCE ISSUE RESOLVED. THE CALLER WOULD BE RETURNING THE LEAD FOR ANALYSIS. IT WAS NOTED THIS WAS AN OUT OF BOX (OOB) ISSUE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13190999 ↗
• MalfunctionDec 17, 2021Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; Material Twisted/Bent

  THE HEALTHCARE PROVIDER REPORTED VIA THE MANUFACTURER REPRESENTATIVE THAT THE LEAD AND GUIDEWIRE WERE BENT IN NEW PACKAGING. THE PACKAGE LOOKED NORMAL WITH NO EXTERIOR DAMAGE. A NEW LEAD WAS OPENED TO REPLACE THE BENT ONE AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13027632 ↗
• MalfunctionNov 10, 2021Positioning 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. IT WAS REPORTED THAT DURING INTRA-OP FOR SCS TRIAL DR COULD NOT DRIVE LEAD UP TO C2. CHANGED TO ANOTHER LEAD AND DR WAS ABLE TO DRIVE AND PLACE TRIAL LEAD EASILY. PATIENT HAS HAD MULTIPLE NECK SURGERIES, MAY HAVE BEEN SCAR TISSUE THAT MADE PLACING THE LEAD DIFFICULT. PATIENT ALSO HAS HARDWARE IN HER NECK. DR WAS USING FLUOROSCOPY WHILE PLACING LEADS. HE REPOSITIONED NEEDLES, TRIED DIFFERENT ENTRY LEVELS, AND TRIED TO DRIVE THE LEADS SEVERAL TIMES. AFTER AN HOUR OF TRYING, DR TRAN ASKED TO TRY A NEW LEAD. WITH THE SECOND LEAD HE WAS ABLE TO PLACE THE LEAD EASILY. ISSUE IS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787230 ↗
• MalfunctionNov 4, 2021Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT  THE PHYSICIAN NOTED THE DISTAL ELECTRODE HAD AN UNUSUAL BEND AND USED A DIFFERENT LEAD FOR THE PROCEDURE. THE ISSUE WAS RESOLVED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12750686 ↗
• MalfunctionOct 12, 2021Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT PRIOR TO SCS TRIAL IT WAS NOTICED THE LEAD HAD AN UNUSUAL BEND IN THE TIP. THE REP OPENED A NEW LEAD AND THIS ONE WAS PULLED OFF THE FIELD. THE UNUSED LEAD IS TO BE RETURNED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12615380 ↗
• MalfunctionJul 19, 2021Break; Break

  REP REPORTED THE DEVICE WAS RETURNED. TRACKING INFORMATION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188269 ↗
• MalfunctionJun 9, 2021Difficult to Insert; Difficult to Insert

  THE HEALTHCARE PROVIDER (HCP) REPORTED VIA THE MANUFACTURER REPRESENTATIVE THAT WHILE CHANGING OUT STYLETS THEY WERE UNABLE TO FEED STYLET INTO THE LEAD. THE HCP SAID HE TRIED MULTIPLE STYLETS AND THEY WOULD NOT GO ALL THE WAY IN. NO EXTERNAL OR PATIENT FACTORS WERE NOTED TO HAVE CONTRIBUTED TO THE ISSUE. THE HCP REPLACED THE LEAD AND THE ISSUE WAS RESOLVED. THERE WERE NO SYMPTOMS AS NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11970287 ↗
• MalfunctionMay 12, 2021Adverse 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, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT LEAD IS ¿CATCHING¿ ON STRAIGHT INTRODUCER NEEDLE. HE HAD DIFFICULTY PASSING AND THEN ELECTRODES WERE CATCHING ON TIP OF NEEDLE WHEN ATTEMPTING TO PULL LEAD BACK. A NEW LEAD WAS USED AND ISSUE WAS RESOLVED. LEAD WAS NEVER IMPLANTED AND WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11815650 ↗
• MalfunctionApr 27, 2021Break; Positioning Problem; Break; Positioning Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REP LOOKED, BUT UNFORTUNATELY WAS UNABLE TO LOCATE THE RECEIPT FOR THE DEVICE TRACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731482 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT HCP SAID THAT THE PATIENT WAS EVALUATED IN THE ER AND THEN WAS SENT HOME. THE PATIENT REPORTS NO SYMPTOMS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11605072 ↗
• MalfunctionFeb 9, 2021High impedance; Insufficient Device Problem Information; High impedance; Insufficient Device Problem Information

  IT WAS REPORTED DURING TRIAL PROCEDURE, THAT LEAD CONTACTS 13, 14 <(>&<)> THEN 9 ( 5, 6 <(>&<)> 2) WERE BROKEN WHEN REP CHECKED THE LEAD CONNECTIVITY DURING TRIAL. THEY REMOVED THE LEADS FROM THE WENS AND RE-INSERTED IT SEVERAL TIMES TO MAKE SURE THE CONTACTS WERE PROPERLY SEATED. THE LEADS WERE CLEANED AND REINSTALLED. THEY STILL SHOWED UP AS DO NOT USE WHEN THE CONNECTIVITY WAS CHECKED.  MANUFACTURER REPRESENTATIVE (REP)  HAD CONCERNS IT MIGHT BE THE WENS, BUT THEY SWITCHED THE LEADS INSIDE THE WENS AND THE SAME CONTACTS SHOWED UP IS BROKEN CONFIRMING THAT THE ISSUE WAS THE LEAD AND NOT THE WENS. EVENTUALLY A THIRD CONTACT ALSO APPEARED TO BE BROKEN. REP USED A DIFFERENT LEAD FROM TRUNK STOCK TO REPLACE THE ONE IN QUESTION. NO PATIENT SYMPTOMS WERE REPORTED. LEAD WOULD BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11301553 ↗
• MalfunctionNov 13, 2020Component Misassembled; Component Misassembled

  THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE HEALTHCARE PROVIDER (HCP) REPORTED TO THEM ON (B)(6) 2020 DURING A PROCEDURE IT WAS DISCOVERED THAT THE TRIAL LEAD KIT CAME WITH 2 CURVED NEEDLES INSTEAD OF ONE STRAIGHT AND ONE CURVED. THEY OPENED A NEW LEAD KIT WHICH HAD THE CORRECT NEEDLES IN IT, WHICH RESOLVED THE ISSUE FOR THE HCP. NO SYMPTOMS REPORTED. THE REP STATED THAT THE DEVICE WAS NOT USED ON THE PATIENT AT ALL SO THE PATIENT HAD NO SYMPTOMS OR ISSUES. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS NOTED THE DEVICE WOULD BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10837094 ↗
• MalfunctionNov 9, 2020Device Damaged Prior to Receipt by User; Impedance Problem; Insufficient Device Problem Information; Device Damaged Prior to Receipt by User; Impedance Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE LEAD HAS IMPEDANCES ALL THE WAY THROUGH ON 0-7 SO  MANUFACTURER REPRESENTATIVE ASKED THE DOCTOR TO RESEAT THE LEAD IN THE WIRELESS EXTERNAL NEUROSTIMULATOR (WENS) AND HE DID AND THEN EVERY CONTACT WAS OUT. SO REP THEN ASKED THE DOCTOR TO MOVE THE LEAD IN THE 8-15 AND IT WAS OUT ON EVERY CONTACT AS WELL. REP THEN REPLACED THE LEAD WITH A NEW LEAD BEING THAT IT WAS AN ISSUE WITH THE LEAD (OUT OF BOX) AND THE NEW LEAD WORKED, ISSUE WAS RESOLVED.  THE CAUSE WAS UNKNOWN. LEAD WAS BEING MAILED BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10808786 ↗
• MalfunctionMar 25, 2020Break; Difficult to Remove; Positioning Problem; Break; Difficult to Remove; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT. THE REP REPORTED THAT THE LEAD WAS DAMAGED DURING A TRIAL PROCEDURE. THE PHYSICIAN PERFORMING THE PROCEDURE ATTEMPTED EPIDURAL ACCESS AND LEAD PLACEMENT BUT WAS UNABLE TO ADVANCE THE LEAD. THE REP REPORTED THAT INSTEAD OF REMOVING THE NEEDLE, HE ATTEMPTED TO REMOVE THE LEAD THROUGH THE NEED AND DAMAGED THE LEAD. THE LEAD WAS NOT REATTEMPTED. THE LEAD WAS CLEARLY DAMAGED AND WOULD BE RETURNED. THE REP REPORTED THAT THE PATIENT WAS NOT INJURED AND 2 LEADS WERE EFFECTIVELY PLACED FOR HIS TRIAL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9879269 ↗
• MalfunctionDec 12, 2019Positioning Problem; Insufficient Device Problem Information; Positioning Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT ON (B)(6) 2019 DURING AN IMPLANT PROCEDURE, THE PHYSICIAN NOTICED THAT THE CURVED TIP NEEDLE FOR THE LEAD KIT WAS DEFECTIVE. THEY STRUGGLED WITH THREADING THE STRAIGHT TIPPED NEEDLE, AND HAD TO RE-ENTER THE EPIDURAL SPACE SEVERAL TIMES. THE PHYSICIAN WAS READY TO ABORT THE CASE BUT THEN WHEN THEY TRIED A SECOND LEAD THEY WERE ABLE TO GET IN THE FIRST TIME USING THE CURVED TIP NEEDLE FROM THE 2ND LEAD KIT. ISSUE WAS RESOLVED. THE REP REPORTED THEY WOULD BE RETURNING THE PRODUCT FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9457338 ↗
• MalfunctionOct 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT. THE REP REPORTED THAT THE TRIAL LEAD WAS DEFECTIVE. THE REP REPORTED THAT THEY COULDN'T USE THE LEAD DUE TO IT HAVING A LARGE CURVE. THE LEAD WAS NEVER USED. THERE WERE NO PATIENT FACTORS THAT COULD HAVE LED TO THE ISSUE. ANOTHER TRIAL LEAD WAS USED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9220993 ↗

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