Vectris™ SureScan® 977A260 (UDI 00643169109391)Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00643169109391), received between Nov 23, 2016 and Aug 14, 2026 — classified as 27 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 19, 2025Break; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Break; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  REP REPORTED THAT THE INS WAS REPLACED DUE TO NORMAL BATTERY DEPLETION.

  Patient problems: Insufficient Information; Pain

  MAUDE report 22839781 ↗
• MalfunctionJul 17, 2025Difficult to Remove; Insufficient Device Problem Information; Difficult to Remove; Insufficient Device Problem Information

  IT WAS REPORTED THAT BEFORE LEAD PLACEMENT, A CURVED PUNCTURE NEEDLE WAS ADVANCED INTO THE EPIDURAL SPACE. WHEN THE INNER STYLET WAS REMOVED, IT FELT DIFFICULT TO PULL OUT. THE PHYSICIAN POINTED OUT THAT THE SHARP BEND AT THE TIP OF THE INNER STYLET MIGHT HAVE MADE IT HARD TO REMOVE. THE ISSUE WAS RESOLVED AFTER INSERTING AND REMOVING THE INNER STYLET SEVERAL TIMES. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530560 ↗
• InjuryJun 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). WHILE ON THE CALL, PATIENT STATED THEY HAD THE LEAD REPLACED IN 2023 DUE TO LEAD FAILURE. AGENT DOCUMENTED INFORMATION GIVEN. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196764 ↗
• InjurySep 24, 2022Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN INDICATIONS. THE REASON FOR CALL WAS PATIENT SAID HER SYSTEM NEVER WORKED, THAT MDT TOLD THE DOCTOR TO PUT THE LEAD IN WRONG. PATIENT SAID HCP REPLACED THE IMPLANT 5 WEEKS LATER. CALLER SAID HCP COULDN'T GET SUPPORT FOR HER AREA, THUS, SHE NEVER USED HER SYSTEM. PATIENT REITERATED THAT IT WAS MDT'S FAULT AND THAT SHE'LL FIND A DOCTOR TO REMOVE THE SYSTEM. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15477547 ↗
• MalfunctionFeb 25, 2022Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT PATIENT DID NOT REPORT ANY SIGNS OR SYMPTOMS ASSOCIATED WITH DEVICE. PHYSICIAN AND SCRUB TECH NOTICED ISSUE (LIQUID IN BATTERY PORT) DURING ROUTINE REPLACEMENT. PHYSICIAN REMOVED LEADS FROM 97714 BATTERY AND NOTICED LIQUID COMING OUT OF ONE OF THE PORTS (BOTTOM PORT). THE LEAD ALSO LOOKED BENT AND WAS DIFFICULT TO PLUG IN TO THE NEW BATTERY. PHYSICIAN WAS ABLE TO PLUG LEAD IN TO NEW BATTERY AND IMPEDANCES WERE ALL GOOD. BATTERY WAS REPLACED WITH 97715.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13603423 ↗
• MalfunctionFeb 9, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT PT IS NEEDING MRI OF THORACIC SPINE (CALLER NOTED THAT THIS SCAN WAS ORDERED (B)(6) 2021) TO ASSESS SCS LEADS. CALLER REPORTS THE PT SAID SHE WAS INFORMED BY HER  HEALTH CARE PROFESSIONAL (HCP) THAT THE LEADS HAD MOVED OR WERE BROKEN. CALLER THEN STATED THAT, PER AN X-RAY OF THE LUMBAR AND THORACIC SPINE DONE IN (B)(6) 2021, HE CAN SEE THAT ONE LEAD IS STILL IN THE EPIDURAL SPACE BUT THE OTHER IS NOT. CALLER REPORTS THIS SECOND LEAD LOOKS TO BE FURTHER DOWN AND INFERIOR TO THE LEAD THAT STILL REMAINS IN THE EPIDURAL SPACE. CALLER ALSO NOTED THAT THE LEAD THAT HAS MOVED LOOKS TO BE JUST UNDER THE SKIN IN SOFT TISSUE. CALLER SPECULATES THIS ISSUE BEGAN IN (B)(6) 2021 GIVEN TIMING OF IMAGING. CALLER IS INQUIRING IF PT CAN HAVE MRI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502450 ↗
• InjuryFeb 1, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT PTS LEADS WERE IN THE WRONG POSITION AND HAD TO BE REALIGNED AND IT WAS BETTER. PT KNEW WHO THEIR  HEALTH CARE PROFESSIONAL (HCP) WERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416730 ↗
• MalfunctionFeb 1, 2022Migration or Expulsion of Device; Battery Problem; Migration or Expulsion of Device; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT THEY WERE GETTING AN ERI MESSAGE, PS REVIEWED AND PT WAS REDIRECTED TO THEIR  HEALTH CARE PROFESSIONAL (HCP). PT NOTED THEY WERE JUST TOLD A FEW WEEKS AGO, IN AN MRI FOR THEIR BACK, THAT ONE OF THE LEADS WERE LOOSE FOR THEY WERE OUT OF POSITION. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416542 ↗
• MalfunctionSep 27, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE LEAD WAS IMPLANTED AFTER THE USE BEFORE DATE OF (B)(6) 2021.  NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12536457 ↗
• MalfunctionFeb 3, 2021High impedance; Energy Output Problem; High impedance; Energy Output Problem

  THE PATIENT REPORTED VIA THE MANUFACTURER REPRESENTATIVE THAT SHE WAS NOT ABLE TO TURN HER STIMULATION UP. IT WAS NOTED THAT THE PATIENT HAD NOT USED THE STIMULATION FOR 1.5 YEARS AS HER PAIN CONTROL HAD BEEN GREAT. IT WAS MENTIONED SHE HAD A FALL FROM A TRUCK BED IN 2019. WHEN THE STIMULATOR WAS INTERROGATED CONTACTS 0-4 WERE FOUND TO ALL BE ABOVE 40000 OHMS. THE PATIENT WAS REPROGRAMMED AROUND THE BAD CONTACTS AND WAS ABLE TO GET GOOD COVERAGE. THE PHYSICIAN WAS INFORMED AND STATED THAT NO REVISION WAS NEEDED IF THE PATIENT HAD GOOD COVERAGE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11275900 ↗
• InjuryDec 16, 2020Break; Break

  THE PATIENT REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE PATIENT WAS ONLY SUPPOSED TO UNDERGO AN IMPLANTABLE NEUROSTIMULATOR REPLACEMENT, BUT AFTER SHE WOKE UP, THE PHYSICIAN HAD INFORMED HER THAT HER LEAD WAS BROKEN, AND THAT THEY HAD TO REPLACE HER LEAD DURING SURGERY. (MANUFACTURER'S RECORDS INDICATE THAT THE PATIENT ONLY HAD 1 LEAD IMPLANTED WITH AN ADAPTOR AND THAT THE ADAPTOR WAS REMOVED AND ANOTHER LEAD WAS PLACED DURING THAT SURGERY. MANUFACTURER'S RECORDS DO NOT INDICATE THAT THE LEAD WAS REMOVED.)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023974 ↗
• MalfunctionOct 14, 2020High impedance; Connection Problem; High impedance; Connection Problem

  THE REP REPORTED THAT THE CAUSE OF THE ISSUE WAS UNKNOWN. THE PHYSICIAN ATTEMPTED TO REMOVE AND REINSERT LEAD INTO BATTERY MULTIPLE TIMES WITH NO SUCCESS. THE REP PROGRAMMED THE PATIENT'S TRIAL SETTINGS WITHOUT USING THIS PARTICULAR ELECTRODE. DTM SETTINGS WERE SUCCESSFULLY PROGRAMMED AND I DID NOT NEED TO USE THIS PARTICULAR ELECTRODE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10680506 ↗
• InjuryDec 12, 2019Unintended Collision; Impedance Problem; Unintended Collision; Impedance Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE AND CONFIRMED TO BE FROM THE HEALTHCARE PROFESSIONAL ON 2019-DEC-12. IT WAS REPORTED THAT PER THE PATIENT THE CHANGE IN COVERAGE WAS RELATED TO A FALL. NO FURTHER COMPLICATIONS WERE REPORTED /ANTICIPATED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 9460065 ↗
• InjuryOct 1, 2019High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT DIDN'T LIKE HAVING A RECHARGEABLE BATTERY SO THE DECISION WAS MADE TO REPLACE IT WITH A NON-RECHARGEABLE BATTERY. DURING THE REPLACEMENT, INTRA-OP IMPEDANCE TESTING SHOWED ALL IMPEDANCES WERE OPEN. THE HCP OPENED ANOTHER NEW INS AND AGAIN ALL IMPEDANCES WERE OPEN. THE LEADS WERE TESTED WITH A WENS AND ALL IMPEDANCES WERE OPEN. THE LEADS WERE REPLACED WITH TWO NEW LEADS AND ALL IMPEDANCES WERE THEN NORMAL. THE REP DIDN'T KNOW WHAT LED TO THE ISSUE. THE ISSUE WAS REPORTED TO BE RESOLVED. THE EXPLANTED LEADS WERE EXPECTED TO BE RETURNED FOR ANALYSIS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9139925 ↗
• InjuryOct 1, 2019High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT DIDN'T LIKE HAVING A RECHARGEABLE BATTERY SO THE DECISION WAS MADE TO REPLACE IT WITH A NON-RECHARGEABLE BATTERY. DURING THE REPLACEMENT, INTRA-OP IMPEDANCE TESTING SHOWED ALL IMPEDANCES WERE OPEN. THE HCP OPENED ANOTHER NEW INS AND AGAIN ALL IMPEDANCES WERE OPEN. THE LEADS WERE TESTED WITH A WENS AND ALL IMPEDANCES WERE OPEN. THE LEADS WERE REPLACED WITH TWO NEW LEADS AND ALL IMPEDANCES WERE THEN NORMAL. THE REP DIDN'T KNOW WHAT LED TO THE ISSUE. THE ISSUE WAS REPORTED TO BE RESOLVED. THE EXPLANTED LEADS WERE EXPECTED TO BE RETURNED FOR ANALYSIS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9139912 ↗
• InjuryMay 22, 2019Failure to Deliver Energy; Insufficient Device Problem Information; Failure to Deliver Energy; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT IMPLANTED FOR NON-MALIGNANT PAIN. THE PATIENT REPORTED THAT THERE WAS AN ISSUE WHERE THEIR LEADS ¿SEPARATED¿ AND STOPPED WORKING, THEREFORE, THE HAD A REVISION DONE AND NEW LEADS WERE IMPLANTED. THE PATIENT STATED THAT THEY ARE NOT SURE EXACTLY WHAT CAUSED THE ISSUE. THEY MENTIONED THAT THEY WERE GETTING INJECTIONS AND THEY TOLD THE HEALTHCARE PROVIDER THAT THEY DIDN¿T FEEL STIMULATION ANYMORE. THE PATIENT HAD AN X-RAY DONE, AND A LEAD ISSUE WAS FOUND. THE REVISION/REPLACEMENT WAS DONE ON (B)(6) 2018, WHICH RESOLVED THE ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 8633655 ↗
• MalfunctionApr 15, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THE LEAD WAS STILL INTACT.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 8515979 ↗
• MalfunctionFeb 13, 2019Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP). THE PATIENT'S INFORMATION WAS UPDATED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8336054 ↗
• MalfunctionFeb 12, 2019Break; Positioning Problem; Break; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED VIA THE MANUFACTURER REPRESENTATIVE THAT THE IMPLANT PROCEDURE HAD DIFFICULTY WITH THE LEAD PLACEMENT WHICH INCLUDED MANY LEAD PASSES. THE HEALTHCARE PROFESSIONAL STATED THAT THE LEAD APPEARED FRAYED. THE LEAD WAS NOT IMPLANTED AND WAS REMOVED FROM THE TABLE IMMEDIATELY. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331533 ↗
• MalfunctionOct 12, 2018Device Damaged Prior to Receipt by User; Material Twisted/Bent; Device Damaged Prior to Receipt by User; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE. IT WAS REPORTED THAT THE STYLETS WERE SENT BACK FOR TESTING. THEY NOTED THAT EVERYTHING WAS FINE DURING THE PROCEDURE AND WITH THE PATIENT- JUST THE STYLET TWISTED/SPIRALED WHILE THE PHYSICIAN WAS REMOVING IT AND IT DIDN'T DO ANYTHING WITH THE IMPLANTED LEAD. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7961292 ↗
• MalfunctionOct 12, 2018Device Damaged Prior to Receipt by User; Material Twisted/Bent; Device Damaged Prior to Receipt by User; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED ONE OF THE LEAD STYLETS WAS TWISTED/SPIRALED WHEN PULLED OUT OF THE LEAD WHEN REMOVED FROM THE PACKAGING. THE MANUFACTURER REPRESENTATIVE COULDN'T REMEMBER WHICH LEAD HAD THIS ISSUE. IT WAS NOTED THAT THE STYLET WOULD BE SENT BACK FOR ANALYSIS. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7961226 ↗
• MalfunctionAug 10, 2018Difficult to Insert; Positioning Problem; Difficult to Insert; Positioning Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) ON 2018-AUG-10. THE REP INDICATED THAT THE DESIGN OF THE LEAD HUB IS THE PRODUCT PROBLEM. THE PATIENT¿S WEIGHT WAS NOT AVAILABLE DUE TO HIPAA. THE DEVICE WOULD NOT BE RETURNED FOR ANALYSIS BECAUSE IT WAS USED IN THE CASE. THIS INFORMATION WAS CONFIRMED WITH THE HEALTHCARE PROFESSIONAL (HCP). NO FURTHER COMPLICATIONS WERE REPORTED/ARE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7772321 ↗
• MalfunctionJul 30, 2018Difficult to Insert; Failure to Advance; Physical Resistance/Sticking; Difficult to Insert

  INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT ADVANCING THE LEAD THROUGH THE TIP OF THE NEEDLE WAS DIFFICULT- THEY FELT RESISTANCE/CATCHING, LIKE THE ELECTRODE WAS CATCHING ON THE TIP. THE HEALTHCARE PROVIDER (HCP) USED A LITTLE FINESSE TO ADVANCE THE LEAD THROUGH THE NEEDLE AND THEY WERE ABLE TO COMPLETE THE CASE. THE IMPEDANCES WERE NORMAL. THE PHYSICIAN NOTED THAT THERE WAS A GRITTY FEELING WHEN WITHDRAWING THE STYLET, WHICH WAS NOT THE USUAL FEELING. ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO SUCCESSFULLY WITHDRAW THE STYLET AND THE CAUSE OF THE DIFFICULTY INSERTING/WITHDRAWING THE LEAD WAS NOT DETERMINED. THIS INFORMATION WAS CONFIRMED WITH THE PHYSICIAN/ACCOUNT. ADDITIONAL INFORMATION RECEIVED. THE PATIENT'S INFORMATION WAS UPDATED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7730780 ↗

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