N/A 97725 (UDI 00763000017590)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00763000017590), received between Dec 11, 2018 and Sep 10, 2021 — classified as 22 injuries, 20 malfunctions.

The most frequently reported specific device problem is “High impedance” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2021High impedance; High impedance

  REP REPORTED THEY HIT CANCEL WITH NO REACTION. THE CASE WAS ALREADY RUNNING LONG FROM THE IMPEDANCE ISSUES AND THE SWAP OUT OF THE LEAD, THEREFORE I ABANDONED THE WENS AND THE TABLET THAT WAS COMMUNICATING WITH IT AND USED A DIFFERENT WENS AND TABLET. THE REPLACEMENT COMBINATION WORKED WELL. THE ISSUE WAS RESOLVED BY NOT USING THE DEVICE. IT WILL BE RETURNED WITH TRACKING NUMBER 9216 2901 3583 9800 4041 74 FOR THE WENS AND 9216 2901 3583 9800 4271 66 FOR THE LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456437 ↗
• InjuryJun 11, 2021Adverse 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). IT WAS REPORTED THAT¿ON (B)(6) 2021 THE PA DID A LEAD PULL ON A TRIAL PATIENT (PT). THE PA NOTICED A DISCHARGE AND SUSPECTED AN INFECTION. THE PT WENT TO THE ER FOR POSSIBLE INFECTION. THE PT COMPLAINED OF LEG WEAKNESS BUT MDT REP SAID THE PT HAS HAD PREVIOUS LEG WEAKNESS. MDT REP REPORTS HE DOES NOT KNOW THE OUTCOME BECAUSE THE PT LEFT THE HOSPITAL. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE CAUSE OF THE DISCHARGE WAS NOT DETERMINED.

  Patient problems: Fluid Discharge; Muscle Weakness/Atrophy; Unspecified Infection

  MAUDE report 11983733 ↗
• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS CLARIFIED THAT THE DEATH WAS NOT RELATED TO THE MANUFACTURER¿S DEVICE. AFTER BOTH LEADS HAD BEEN PLACED THE CRNA TOLD THE PHYSICIAN THE PULSE OXIMETRY HAD DECLINED SIGNIFICANTLY. IT WAS NOTED THAT THE PULSE OXIMETRY HAD BEEN FLUCTUATING DURING THE ENTIRE PROCEDURE, HOWEVER, THE CRNA DIDN¿T MENTION THAT TO THE PHYSICIAN UNTIL THE PULSE OXIMETRY SIGNIFICANTLY DECLINED WHICH WAS AT THE VERY END OF THE TRIAL. THERE WERE NO DEVICE ISSUES AND IMPEDANCES WERE CHECKED AND WERE FINE. IT WAS FURTHER CLARIFIED THAT THE PATIENT WENT INTO ASYSTOLE AT THE FACILITY WHERE THE TRIAL WAS TAKING PLACE AND REMAINED IN ASYSTOLE AFTER THE PARAMEDICS TRANSPORTED HER TO THE HOSPITAL. NO OTHER MEDICAL EVENTS OR PROCEDURES WERE KNOWN TO HAVE OCCURRED IN THE TIME LEADING UP TO THE DEATH.

  Patient problems: Cardiac Arrest; Insufficient Information

  MAUDE report 11504934 ↗
• InjuryDec 9, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT HAD ONE OF THEIR TRIALING LEADS REMOVED BECAUSE OF RIB PAIN. FACTORS THAT MAY HAVE LED TO THE REPORTED ISSUE WAS LEAD MIGRATION. THE PATIENT CONTACTED THE TRIALING PHYSICIAN  TO HAVE THE LEADS REMOVED THE MORNING AFTER THEY WERE PLACED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE LEAD WOULD NOT BE RETURNED FOR ANALYSIS AS THE CUSTOMER DISCARDED IT. THE TRIAL BEGAN ON (B)(6) 2020 AND THE LEAD WAS REMOVED ON (B)(6) 2020.

  Patient problems: Pain

  MAUDE report 10978063 ↗
• MalfunctionOct 5, 2020Failure to Deliver Energy; High impedance; Failure to Deliver Energy; High impedance

  THE MANUFACTURING REPRESENTATIVE (REP) REPORTED A SPINAL CORD STIMULATION TRIAL WAS PERFORMED ON (B)(6) 2020. WHEN ONE LEAD WAS PLACED IN THE EPIDURAL SPACE, AND CONNECTED TO A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS), STIMULATION WAS ACTIVATED. THE PATIENT COULD FEEL NO PARESTHESIA. IMPEDANCES WERE CHECKED, AND WERE FOUND TO BE ALL >10,000. LEAD CONNECTIVITY WAS GOOD. FIRST LEAD WAS EXPLANTED, AND SECOND LEAD WAS PLACED WITH THE SAME RESULTS. AN ADDITIONAL WENS WAS TRIED, WHICH PRODUCED THE SAME RESULTS. THE SECOND LEAD WAS EXPLANTED, AND A THIRD LEAD WAS PLACED PRODUCING THE SAME RESULTS. THE TRIAL WAS ABORTED, AND THE ISSUE RESOLVED. PHYSICIAN REQUESTED THAT THE PRODUCT BE RETURNED FOR ANALYSIS. THERE WERE HIGH IMPEDANCES, AND NO STIMULATION FELT. THERE WERE NO KNOWN ENVIRONMENTAL, OR PATIENT FACTORS LED TO, OR CONTRIBUTED TO THE EVENT.

  Patient problems: Insufficient Information; Therapeutic Effects, Unexpected

  MAUDE report 10627234 ↗
• MalfunctionOct 5, 2020Failure to Deliver Energy; High impedance; Failure to Deliver Energy; High impedance

  THE MANUFACTURING REPRESENTATIVE (REP) REPORTED A SPINAL CORD STIMULATION TRIAL WAS PERFORMED ON (B)(6) 2020. WHEN ONE LEAD WAS PLACED IN THE EPIDURAL SPACE, AND CONNECTED TO A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS), STIMULATION WAS ACTIVATED. THE PATIENT COULD FEEL NO PARESTHESIA. IMPEDANCES WERE CHECKED, AND WERE FOUND TO BE ALL >10,000. LEAD CONNECTIVITY WAS GOOD. FIRST LEAD WAS EXPLANTED, AND SECOND LEAD WAS PLACED WITH THE SAME RESULTS. AN ADDITIONAL WENS WAS TRIED, WHICH PRODUCED THE SAME RESULTS. THE SECOND LEAD WAS EXPLANTED, AND A THIRD LEAD WAS PLACED PRODUCING THE SAME RESULTS. THE TRIAL WAS ABORTED, AND THE ISSUE RESOLVED. PHYSICIAN REQUESTED THAT THE PRODUCT BE RETURNED FOR ANALYSIS. THERE WERE HIGH IMPEDANCES AND NO STIMULATION FELT. THERE WERE NO KNOWN ENVIRONMENTAL, OR PATIENT FACTORS LED TO, OR CONTRIBUTED TO THE EVENT.

  Patient problems: Insufficient Information; Therapeutic Effects, Unexpected

  MAUDE report 10627205 ↗
• InjurySep 17, 2020High impedance; High impedance

  MPXR 757573: INFORMATION WAS REPORTED THAT FROM THE MANUFACTURING REPRESENTATIVE (REP) AND HCP THE LEAD WAS NOT CONNECTING TO THE WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). THE LEAD WAS TESTED IN BOTH 0-7 AND 8-15. THE SAME THREE ELECTRODES WERE NOT CONNECTING (ELECTRODES 3, 4, AND 7) FOR 0-7 CONNECTION. 11, 12, AND 15 FOR THE 8-15 CONNECTION. THE REP TRIED A NEW LEAD WHICH WORKED NORMALLY. IT WAS NOTED THAT SURGICAL INTERVENTION DID OCCUR. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION WAS REPORTED THAT THE CAUSE OF THE CONNECTION ISSUE WAS DUE TO THE FAULTY LEAD.

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

  MAUDE report 10548943 ↗
• InjuryAug 31, 2020High impedance; High impedance

  INFORMATION WAS RECEIVED BY A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WITH A WIRELESS EXTERNAL NEUROSTIMULATOR ( WENS). IT WAS REPORTED THAT AFTER THE FIRST LEAD WAS INSERTED INTO THE WENS AND IMPEDANCES WERE CHECKED, IT WAS GOOD AND COVERAGE WAS OVER THE PROPER AREA. WHEN THE SECOND LEAD WAS INSERTED, BOTH LEADS SHOWED IMPEDANCES ABOVE 40K ON THE MAJORITY OF ELECTRODES. THE LEADS AND WENS WERE WIPED AND THERE WERE STILL IMPEDANCES SO A NEW WENS WAS USED. THE WENS SHOWED THE SAME IMPEDANCES. THE ORIGINAL WENS WAS USED AND THE LEADS ENTRANCE AND TRACK WAS RE-INTRODUCED AND THE IMPEDANCE ISSUE WAS RESOLVED.

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

  MAUDE report 10470952 ↗
• MalfunctionAug 3, 2020Therapy Delivered to Incorrect Body Area; Malposition of Device; Therapy Delivered to Incorrect Body Area; Malposition of Device

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS) FOR THE TREATMENT OF COMPLEX REG PAIN SYNDROME IN THE LEFT LEG. THE TRIAL PICTURE SHOWED STAGGERED LEAD PLACEMENT FROM MID T8-T11. THE SPECIALIST REQUESTED THE SURGEON PLACE THE LEAD AT T9-T10. THE PHYSICIAN DID A LAMI LEAD WITH NO XRAY VERIFICATION IN LATERAL POSITION. THE LEAD WAS PLACED AT T6-T7. THE PATIENT WAS RECEIVING RIGHT RIB STIMULATION. THE DEVICE WAS REMOVED AND THE PATIENT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED THAT THE LEAD PLACEMENT AND RIB STIMULATION WERE NOTED THE DAY OF THE PROCEDURE (B)(6) 2020. THE CAUSE OF THE ISSUE WAS DETERMINED ¿ THE LEAD WAS NOTED TO BE TOO FAR OVER TO THE RIGHT AND PLACED AT T7-8. THE PATIENT WAS ALSO PLACED IN THE LATERAL POSITION AND NO X-RAY WAS DONE TO VERIFY WHERE THE LAMINECTOMY WAS AT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10359180 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP AND IT WAS REPORTED THAT THE CAUSE OF THE EPIDURAL BLEED AND INCREASED PAIN WAS NOT DETERMINED. THE ISSUE HAPPENED ON THE SAME DAY AS TRIAL. THE ASSUMPTION IS IT WAS CAUSED BY THE TRIAL PROCEDURE. THE TRIAL PROCEDURE WAS NORMAL AND THERE WERE NO ISSUES DURING PROCEDURE.THE PATIENT FIRST CALLED THE MANUFACTURING REPRESENTATIVE (REP) AND HEALTHCARE PROVER (HCP) ABOUT 4-5 HOURS AFTER PROCEDURE. THE REP TOLD THE PATIENT TO TURN STIM OFF AND THE HCP TOLD HIM TO GO TO THE ER. THE TRIAL WAS ABORTED AND THE LEAD WAS PULLED. THE PATIENT IS NO LONGER IN THE HOSPITAL AND IS AT HOME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 10356149 ↗
• MalfunctionJul 28, 2020High impedance; Device Damaged Prior to Receipt by User; High impedance; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED BY A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE IMPEDANCE MEASUREMENTS WERE 40K ON MULTIPLE CONTACTS PRIOR TO USE. THE LEAD CONNECTIVITY SHOWED BAD CONNECTION. THE LEAD WAS REPOSITIONED IN THE WENS A FEW TIMES AND IMPEDANCES WERE WRONG. THE WENS WAS CHANGED AND CONNECTIVITY WAS WRONG. THE LEAD WAS THEN REPLACED AND A NEW LEAD/WENS RESOLVED THE ISSUE. THE WENS AND LEAD WITH THE HIGH IMPEDANCE WERE EXPECTED TO BE RETURNED FOR ANALYSIS. NO SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10332449 ↗
• MalfunctionJul 21, 2020High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER AND A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE TRIAL LEAD SHOWED IMPEDANCES WHICH SHOWED AVOID OR DO NOT USE WHEN TRYING TO INTRAOPERATIVELY TEST. IT WAS NOTED IT WAS A VERY DIFFICULT LEAD PLACEMENT. MULTIPLE ATTEMPTS WERE MADE TO PLACE THE LEAD, HOWEVER THE PATIENT HAD A LARGE AMOUNT OF SCAR TISSUE IN THEIR EPIDURAL SPACE WHICH MADE PLACEMENT DIFFICULT. IMPEDANCES WERE RUN MULTIPLE TIMES. THE LEAD WAS MOVED SLIGHTLY AND IMPEDANCES WERE RUN, PORTS ON THE WENS WERE SWITCHED AND THE SAME HIGH IMPEDANCES WERE RECEIVED. THE LEAD WAS REMOVED AND ANOTHER WAS TRIED. THE ISSUE WAS RESOLVED AT THE TIME OF REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10303556 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER VIA MANUFACTURER'S REPRESENTATIVE REGARDING A PATIENT WHO WAS TRIALING FOR A NEUROSTIMULATOR FOR SPINAL CORD STIMULATION. IT WAS REPORTED THAT THE TRIAL LEADS WERE EXPLANTED DUE TO AN MRI SHOWING EPIDURAL HEMATOMA. HEMATOMA WAS SURGICALLY REMOVED. THE TRIAL LEADS AND WENS WERE DISCARDED. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Hematoma

  MAUDE report 10295451 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT WAS STILL IN DISCOMFORT/PAIN RIGHT AFTER THE PROCEDURE IN POST-OPERATIVE. THE REP REPORTED THAT AT THAT TIME, STIMULATION WASN¿T TURNED ON OR PROGRAMMED. THE PATIENT WAS STILL IN DISCOMFORT/PAIN DURING THE WEEKEND, THEREFORE THE HEALTHCARE PROVIDER (HCP) ENDED UP PULLING THE LEAD OUT YESTERDAY. THE PATIENT¿S DISCOMFORT/PAIN DIDN¿T CHANGE WITH THE STIMULATION OFF OR ON. THE REP REPORTED THAT THE PATIENT DIDN¿T CALL THEM BACK, SO THEY DIDN¿T KNOW HOW HE WAS DOING AFTER THE LEAD PULL, BUT THEY THOUGHT THE HCP WAS GOING TO HAVE THE PATIENT GET IMAGING DONE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Pain; Therapeutic Effects, Unexpected

  MAUDE report 10134005 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CONSUMER REPORTED THAT WHEN THEY TOOK THE EXTERNAL NEUROSTIMULATOR (ENS) OUT IT WAS FOUND THERE WAS A LITTLE INFECTION IN THE AREA WHERE THE LEADS WERE COMING INTO THE ENS. IT WAS STATED THAT THE INFECTION WAS NOT IN THE SPINAL CORD OR BRAIN, IT WAS JUST IN THE AREA WHERE THE DEVICE WAS. NO DEVICE ISSUES REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 9986338 ↗
• MalfunctionMar 31, 2020Break; Break

  THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE TRIAL LEAD FRACTURED AND WAS REPLACED WITH ANOTHER LEAD. THERE WAS NO ISSUE TO THE PATIENT AND THE PROBLEM WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9904522 ↗
• MalfunctionMar 18, 2020Mechanical Problem; Energy Output Problem; Mechanical Problem; Energy Output Problem

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) AND CONSUMER REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED FROM THE REP STATING THEY WERE ON THE PHONE WITH THE PATIENT AND COACHED THEM THROUGH CHANGING GROUP ON THE PATIENT CONTROLLER. THEY WERE TRYING TO HAVE THEM TURN THE STIMULATION OFF THEN LOWER MA BEFORE CHANGING TO THE NEXT GROUP BECAUSE THEY TOLD THE REP THAT THE SETTINGS FROM DAY BEFORE ON GROUP A WERE TOO STRONG AS THE DAY PROGRESSED. AFTER MULTIPLE ATTEMPTS TO PRESS THE WHITE ON/OFF BUTTON ON TOP OF THE CONTROLLER, THEY WERE UNABLE TO PRESS THE BUTTON TO GET THE SCREEN TO TURN OFF. THEY PRACTICED THIS STEP SEVERAL TIMES THE DAY BEFORE IN PACU (POST-ANETHESIA CARE UNIT) AND IT WAS A LITTLE DIFFICULT TO THEM DUE TO AGE, STRENGTH, AND DEXTERITY. THE PATIENT WAS WARNED THAT THEY WILL LIKELY HAVE TO DECREASE AS SOON AS SWITCHING TO GROUP C AND TO MAKE SURE THEY WERE SITTING DOWN. WHEN THEY CHANGED, THE PATIENT GOT EXTREME SHOCK AND STARTED TURNING DOWN, BUT THEY FELL TO THE FLOOR BEFORE THEY COULD GET LOW ENOUGH. THE REP SPOKE TO THE PATIENT THE NEXT DAY AND THE PATIENT REPORTED THEIR LEG AND GROIN HURT AND THEY WERE GOING TO URGENT CA

  Patient problems: Device Overstimulation of Tissue; Electric Shock; Fall; Hip Fracture; Pain

  MAUDE report 9849074 ↗
• MalfunctionMar 9, 2020High impedance; Insufficient Device Problem Information; High impedance; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL CORD STIMULATION. IT WAS REPORTED THAT 8-15 LEAD WOULD NOT STAY IN CONTACT WITH WENS DURING THE PATIENT'S TRIAL. THE REP FIXED IT DURING THE MID-TRIAL APPOINTMENT BUT IT WAS BACK OUT WHEN THE REP SAW HER AT LEAD PULL. IMPEDANCES WERE CHECKED AND WERE HIGH ON ALL CONTACTS IN 8-15. AFTER FIXING IT AT THE MID TRIAL APPOINTMENT, THEY WERE ALL WITHIN NORMAL RANGE. AT THE LEAD PULL AN IMPEDANCE CHECK SHOWED THEY WERE ALL HIGH AGAIN. LEADS WERE PULLED ON 2/25 DUE TO END OF TRIAL. ISSUE RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9806915 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE FROM A HEALTH CARE PROFESSIONAL REGARDING A PATIENT WHO WAS UNDERGOING A TRIAL FOR SPINAL CORD STIMULATION. IT WAS REPORTED THAT THE PATIENT HAD A TRIAL LEAD PLACED ON (B)(6) 2020. THE HEALTH CARE PROFESSIONAL DID A PARTIAL LAMINECTOMY TO GET THIS LEAD INTO PROPER POSITION IN THE CERVICAL SPINE. THE PATIENT HAD PAIN RELATED TO THE LAMINECTOMY AND DRAINAGE. THE PATIENT WAS SEEN ON (B)(6) 2020 FOR THE LEAD PULL, AND THE LEAD WAS FULLY REMOVED AND DISCARDED. IT WAS NOTED THAT THE PATIENT MAY HAVE A POSSIBLE INFECTION. THE PATIENT HAS A FEVER AND WAS PUT ON ANTIBIOTICS ON (B)(6) 2020. IT REMAINS UNKNOWN IF THE ISSUE WAS RESOLVED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: Fever; Fluid Discharge; Pain; Unspecified Infection

  MAUDE report 9794050 ↗
• MalfunctionFeb 19, 2020Break; High impedance; Stretched; Break; High impedance; Stretched

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WITH A WIRELESS EXTERNAL NEUROSTIMULATOR ( WENS). IT WAS REPORTED THAT DURING INTER-OPERATIVE TESTING, THERE WERE CONNECTIVITY ISSUES WITH CONTACTS 4, 11, AND 12. IT WAS REPORTED THAT IMPEDANCES WERE GREATER THAN 10,000 OHMS (HIGH IMPEDANCES) ON THOSE CONTACTS AS WELL. THERE WERE NO KNOWN FACTORS THAT CONTRIBUTED TO THE ISSUE. THE PHYSICIAN SWITCHED THE CHANNELS AND THE CONNECTIVITY ISSUES WERE CONSISTENT WITH THE LEAD REGARDLESS OF THE CHANNEL. THEY REQUESTED A DIFFERENT WENS SINCE IT TOOK EXTRA EFFORT TO GET THE LEADS IN AND THE SAME RESULT HAPPENED WITH THE SECOND WENS. THEY DID NOT WANT TO REMOVE THE LEADS THE REP PROGRAMMED AROUND THE IMPEDANCES. IT WAS REPORTED THAT THE PATIENT HAD A SUCCESSFUL TRIAL AFTER THE REP PROGRAMMED AROUND THE IMPEDANCES. IT WAS NOTED THAT THE HEALTHCARE PROVIDER (HCP) UNFORTUNATELY STRETCHED THE LEADS OUT A LITTLE AT THE LEAD PULL, WHICH THE REP MENTIONED THEY HAD NEVER SEEN HAPPEN WITH THE LEADS SO THEY NOTED THAT IT MAY HAVE SOMETHING TO DO WITH THE IMPEDANCES. THE TRIAL BEGAN ON (B)(6) 2020 AND WAS COMPLETED ON (B)(6) 2020. IT WAS INDICATED THAT THE LEADS AND

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9729867 ↗
• InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE FROM A HEALTH CARE PROFESSIONAL REGARDING A PATIENT WHO STARTED UNDERGOING A SPINAL CORD STIMULATION TRIAL ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF PAIN AT THE LEAD SITE. THE HEALTH CARE PROFESSIONAL UNDRESSED THE SITE AND NOTED DISCHARGE AT THE LEAD ENTRY SITE. A CULTURE WAS TAKEN FOR A POSSIBLE INFECTION, AND THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR FURTHER WORK UP. ALL OF THE EQUIPMENT WAS DISPOSED OF. NO SURGICAL INTERVENTION WAS PLANNED OR PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: Discharge; Fluid Discharge; Pain; Unspecified Infection

  MAUDE report 9678727 ↗
• InjuryJan 21, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE FROM A HEALTH CARE PROFESSIONAL REGARDING A PATIENT WHO STARTED UNDERGOING A TRIAL OF A SPINAL CORD STIMULATION SYSTEM ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NAUSEA AND VOMITING, CHILLS, AND SHAKING DURING THE SPINAL CORD STIMULATION TRIAL. THE PATIENT WAS PLACED ON ANTIBIOTICS DURING THE TRIAL. THE IMPEDANCE VALUES WERE CHECKED, AND LEAD POSITIONING WAS VERIFIED VIA X-RAY. THE HEALTH CARE PROFESSIONAL REPOSITIONED THE TRIAL LEAD ON (B)(6) 2019 AS IT APPEARED TO HAVE MIGRATED. THE HEALTH CARE PROFESSIONAL QUESTIONED WHETHER THERE WAS AN ALLERGIC REACTION TO THE LEAD WHEN REPORTING THE ISSUE/COMPLAINT. THE LEAD WAS EXPLANTED PER PATIENT REQUEST AND DISCARDED ON (B)(6) 2019 TO RESOLVE THE ISSUE. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Chills; Hypersensitivity/Allergic reaction; Nausea; Shaking/Tremors; Vomiting

  MAUDE report 9611450 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE, REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT HAD A TRIAL ON (B)(6) AND HAD THE LEADS REMOVED ON (B)(6). PATIENT WENT HOME AND COMPLAINED OF BACK PAIN. DOCTOR WENT OVER REASONS TO CALL BACK OR BE SEEN AND ADVISED IF PAIN GETS WORSE THEN GO TO ER. THERE WERE NO EXTERNAL FACTORS THAT MAY HAVE LED TO OR CONTRIBUTED TO THE ISSUE. NO TROUBLESHOOTING WAS DONE. PATIENT'S WEIGHT WAS ASKED BUT UNKNOWN. HCP HAD NO FURTHER INFORMATION. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED THAT THE PATIENT HAD A TRIAL PERFORMED WITH THE PERMANENT IMPLANT IN PLACE. THE LEAD AND THE WENS SERIAL NUMBER WAS PROVIDED. THE PATIENTS BACK PAIN WAS RESOLVED BY PATIENT GOING TO THE ER AND THEN SENT TO ICU. THE BACK PAIN WAS NOT RESOLVED. DEVICE REMOVAL IS STILL UNKNOWN. THE PROVIDED INFORMATION WAS CONFIRMED WITH THE HCP. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPL

  Patient problems: Pain; Sepsis

  MAUDE report 9586955 ↗
• MalfunctionDec 16, 2019Break; Device Damaged Prior to Receipt by User; Impedance Problem; Break; Device Damaged Prior to Receipt by User; Impedance Problem

  ADDITIONAL INFORMATION WAS REPORTED THAT THE CAUSE OF THE BAD CONTACTS WAS UNKNOWN. THE LEAD WAS NEVER IMPLANTED IN THE PATIENT. THIS WAS AN OUT OF BOX FAILURE. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9474998 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT. THE HCP REPORTED THAT THE PATIENT COULDN¿T MOVE HIS LEGS AND REMAINED IN THE HOSPITAL. THERE WERE NO CONTRIBUTING FACTORS IDENTIFIED AND THERE WERE NO TROUBLESHOOTING STEPS PERFORMED. THE HCP TRAILED THE PATIENT ON (B)(6) 2019 AND THEN REMOVED THE LEADS THE FOLLOWING DAY BECAUSE THE PATIENT WAS CONFUSED AND IN THE HOSPITAL. THE PATIENT HAD TO HAVE A LAMINECTOMY FOR BLEEDING DURING THE WEEK PRIOR. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: Ambulation or Postural Difficulties; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9434280 ↗

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