NA 97725 (UDI 00763000278762)Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00763000278762), received between Mar 29, 2021 and Jun 4, 2024 — classified as 60 injuries, 34 malfunctions.

The most frequently reported specific device problem is “High impedance” (17 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 94 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT THE TRIAL WAS STARTED WITHOUT ISSUE AND THE WENS WAS WORKING WELL. IT WAS LATER NOTED THAT THE WENS WAS EXPIRED, WITH EXPIRATION DATE OF JUNE 2023. THE REP WILL SUBMIT ANY NEW INFORMATION THAT BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463278 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, OTHER) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTER NAL NEUROSTIMULATOR (ENS). PATIENT REPORTED EXTREME PROCEDURAL PAIN, THAT SHE CAN¿T SIT OR SLEEP, FEELING ¿VIBRATION IN HER BODY¿ WITH THE DEVICE OFF, ¿BURNING FEELING¿ WITH THE DEVICE OFF AND THAT HER HANDS ARE SHAKING ALSO WITH THE DEVICE OFF. ALL IMPEDANCES NORMAL AT TIME OF PROGRAMMING IN POST OP. THE TRIAL DEVICE WAS REMOVED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: Ambulation or Postural Difficulties; Burning Sensation; Insufficient Information; Pain; Shaking/Tremors; Sleep Dysfunction

  MAUDE report 18312122 ↗
• MalfunctionNov 29, 2023High impedance; High impedance

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT THERE IS NO IMPACT TO THE PATIENT. ENCOUNTERED HIGH IMPEDANCES ON ALL CONTACTS DURING INTRAOP TESTING RANGING FROM 5000-9000 OHMS. OBTAINED ¿ORANGE¿ ZONE FOR ALL CONTACTS.  NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS TO REPORT. DURING INTRAOP TESTING ON 5/11/22, ATTEMPTED TO RESEAT THE LEAD IN THE WENS. ATTEMPTED REPOSITIONING OF LEAD. REPLACED LEAD WITH ANOTHER 977D260 AND INITIALLY RAN INTO SAME PROBLEM BUT THEN IMPEDANCES RESOLVED TO NORMAL. REPLACED LEAD WITH ANOTHER LEAD AS MENTIONED ABOVE AND REPLACED WENS AS WELL. ISSUE WAS THEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18231201 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. REP REPORTED HCP HAD SURGERY TO EVACUATE THE HEMATOMA ON (B)(6) 2023. PATIENT HAD AN ID ON (B)(6) 2023 DUE TO AN INFECTION IN THE INCISION. PATIENT HAD A PIC LINE FOR ANTIBIOTICS AND WAS REFERRED TO INFECTIOUS DISEASE. PATIENT HAD A OFFICE VISIT ON (B)(6) 2023 AND ACCORDING TO THE MEDICAL ASSISTANT, THE WOUND LOOKS GOOD NOW.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 18111636 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS IN LEGS IMMEDIATELY AFTER TRIAL PROCEDURE. THE CAUSE IS UNKNOWN, BUT THE ISSUE WAS RESOLVED BY REMOVAL OF THE DEVICE IMMEDIATELY AFTER TRIAL. THE DEVICES WERE RETURNED FOR ANALYSIS. ON (B)(6) 2023 THE REP REPORTED CLARIFICATION THAT THE DEVICE REMOVAL OCCURRED IMMEDIATELY AFTER THE TRIAL PROCEDURE. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 18043399 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. THE REP PROVIDED DEVICE SERIAL NUMBERS. IT IS CURRENTLY UNKNOWN IF THE INFECTION HAS BEEN RESOLVED, THE PATIENT WAS SEEKING TREATMENT AS INPATIENT AT A HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 17953705 ↗
• MalfunctionOct 17, 2023Failure to Deliver Energy; Failure to Deliver Energy

  ADDITIONAL INFORMATION WAS RECEIVED, FROM A HEALTHCARE PROVIDER (HCP). REPORTING, THAT THIS PATIENT/EVENT WAS REGARDING AN SCS TRIAL. SERIAL NUMBERS FOR THE WIRELESS EXTERNAL NEUROSTIMULATOR (WENS) AND TRIAL LEADS WERE REPORTED. ***MDR DECISION CORRECTED TO NOT REPORTABLE. ***

  Patient problems: Insufficient Information

  MAUDE report 17951190 ↗
• InjuryOct 2, 2023Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). PATIENT SAID SHE FELT ITCHY WHEN DEVICE WAS TURNED ON. SHE ALSO HAD INCREASED PAIN IN THE MIDDLE OF HER BACK AFTER PROCEDURE. DOCTOR SAID IT COULD BE POSSIBLE HEMATOMA. PATIENT ALSO HAD BLISTERING ON BACK FROM THE TAPE. TROUBLESHOOTING WAS PERFORMED. PATIENT LEADS WERE LOOKED AT, WHICH HAD MOVED FROM T8 TO T9. PATIENT WAS REPROGRAMMED FROM DTM TO LD PROGRAMMING. PROVIDER RETAPED BACK, NOTICED BLISTERING, AND DRIED BLOOD ON GAUZE. PATIENT WAS TOLD THAT IF IT GETS WORSE, OR PAIN INCREASES, TO GO TO THE HOSPITAL. DEVICE WERE REMOVED/ DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Itching Sensation; Pain; Skin Inflammation/ Irritation

  MAUDE report 17851463 ↗
• MalfunctionSep 21, 2023Failure to Interrogate; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Failure to Interrogate; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  REP PROVIDED DEVICE SERIAL NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788857 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT (PT) VIA MANUFACTURER REPRESENTATIVE (REP) WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). THE PATIENT REPORTED TO THE REP THEY FELT NAUSEOUS LAST NIGHT AND WALKED TO THE BATHROOM AND LOST CONSCIOUSNESS. THE PT'S HUSBAND CALLED EMERGENCY SERVICES AND PT WAS TRANSPORTED TO EMERGENCY DEPARTMENT. THE PT STATED THEY HAD LAB WORK AND A CT SCAN PERFORMED. PT WAS DISCHARGED TO GO HOME. TROUBLESHOOTING WAS NOT PERFORMED, AND THE CAUSE IS NOT KNOWN. THE ISSUE HAS NOT YET BEEN RESOLVED.

  Patient problems: Loss of consciousness; Nausea

  MAUDE report 17738757 ↗
• MalfunctionAug 24, 2023Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THE TRIAL LEADS DID NOT SLIP. PATIENT WAS REFERRED TO NEUROSURGERY TO DISCUSS REMOVAL. WEIGHT WAS REPORTED. DEVICE DISPOSITION WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612997 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) . IT WAS REPORTED THAT THERE WAS SEVERE LEG PAIN AFTER TRIAL LEAD PLACEMENT. THE PATIENT RECEIVED PAIN MEDICATION, HAD AN ER VISIT AND HAD THEIR TRIAL LEADS PULLED. THE ISSUE IS ONGOING. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE. 2023-JUL-27 E1 (REP): NO NEW INFORMATION.

  Patient problems: Pain

  MAUDE report 17444248 ↗
• InjuryAug 2, 2023Malposition of Device; Malposition of Device

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT WAS HAVING MUSCLE SPASMS IN THEIR ABDOMEN. TESTED WITH STIMULATION OFF AND ON. PATIENT CONTINUED TO HAVE SPASMS WITH THE STIMULATION OFF AND WITH IT ON. THE SPASMS NOT SEEM TO CORRELATE SPECIFICALLY TO THE STIMULATION. THE HCP REVIEWED THE X-RAY, AND CONFIRMED LEADS WERE POSTERIOR. THE TRIAL LEADS WERE EXPLANTED. A RE-TRIAL WILL BE ATTEMPTED OR PLANED IN THE FUTURE. THE ISSUE WAS RESOLVED.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 17442806 ↗
• InjuryJul 27, 2023Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT STATED THEY WERE OVER STIMULATED DURING INTRA- OP TESTING WHICH CAUSED HIS LEG TO BE ¿SHOCKED¿ AND HE BELIEVES HE HIT HIS FOOT ON THE TABLE. PATIENT NOW STATES HE BELIEVES HIS TOE IS BROKEN RELATED TO THE EVENT. THE 4TH TOE ON THE RIGHT FOOT IS BRUISED AND SWOLLEN. PATIENT STATES HIS PHYSICAL THERAPISTS RECOMMENDED TAPING IT TO HIS ADJACENT TOE.

  Patient problems: Bone Fracture(s); Bruise/Contusion; Device Overstimulation of Tissue; Electric Shock; Swelling/ Edema

  MAUDE report 17409641 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT IT IS UNKNOWN IF PT WAS OPERATED ON. MANUFACTURER REPRESENTATIVE (REP) WAS NOTIFIED BY THE HEALTHCARE PROVIDER (HCP) THAT PT WAS DISCHARGED FROM HOSPITAL THE NEXT DAY. HCP NOTIFIED REP ON ON THE DISCHARGE DATE THAT THE SPINAL CORD SYSTEM DEVICE WAS STILL INSIDE OF BODY AND DIRECTED REP TO CALL PT TO TURN ON DEVICE. HCP STATED THEY WOULD PULL LEADS. IT IS UNKNOWN IF ISSUE HAS BEEN RESOLVED AND IF LEADS WERE REMOVED AS REP WAS NOT ABLE TO BE PRESENT FOR LEAD PULL.

  Patient problems: Aneurysm; Dysphasia; Insufficient Information

  MAUDE report 17407825 ↗
• MalfunctionJul 24, 2023High impedance; Adverse Event Without Identified Device or Use Problem; High impedance; 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. DURING TRIAL PROCEDURE ON (B)(6), NEW TRIAL LEAD SHOWING HIGH IMPED, >40,000 ON #4. THEY SWITCHED LEAD INTO OTHER ENS LEAD CHANNEL AND THE HIGH IMPED FOLLOWED THE ELECTRODE (#12). THERE WAS NO VISIBLE DAMAGE TO THE LEAD. THEY DIDN'T DO ANY TRIALING AND REPLACED LEAD WITHOUT INCIDENT. LEAD IN QUESTION IS BEING SENT BACK. CALLER SAYS THAT HCP INVOLVED DOES NOT NEED ANY ANALYSIS RESULTS SENT TO THEM. PT WEIGHT IS 155 LBS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377731 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT WAS HAVING STOMACH PAIN RADIATING TO BACK AROUND 9PM ON (B)(6), 2023. DEVICE WAS TURNED OFF WHEN PAIN BEGAN. PT REPORTED GOING TO ER DUE TO STOMACH PAIN AROUND 2-3AM ON (B)(6), 2023. SPOKE WITH PT HUSBAND ON (B)(6), 2023 AND HE STATED THEY WERE HOME FROM ER AND PT WAS ASLEEP. PT STATED BEING GIVEN A LAXATIVE AT ER TO HELP WITH HAVING A BOWEL MOVEMENTBUT REPORTS STILL UNABLE TO. ON (B)(6), 2023 PT REPORTS UNABLE TO MOVE LOWER EXTREMITIES AND WAS DIRECTED TO CALL 911. DEVICE HAS BEEN TURNED OFF SINCE EVENING ON (B)(6), 2023. IT WAS LATER REPORTED THAT THE PATIENT HAS HAD 2 SEPARATE OPERATIONS TO DECOMPRESS AN EPIDURAL HEMATOMA. THE ISSUE REMAINS ONGOING AT THIS TIME.

  Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Constipation; Hematoma

  MAUDE report 17353251 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT VIA A HEALTHCARE PROVIDER AND MANUFACTURER REPRESENTATIVE (REP) ON (B)(6) 2023. REP REPORTED THAT THEY SPOKE WITH THE MEDICAL STAFF FROM THE OFFICE TODAY WHO REPORTED SHE SPOKE WITH THE PATIENT EARLIER TODAY. SHE STATED PATIENT REPORTED HE REMAINS IN THE HOSPITAL AND IS EXPERIENCING NUMBNESS TO FEET AND DIFFICULTY AMBULATING. NO FURTHER DETAILS WERE KNOWN.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Numbness; Pain

  MAUDE report 17225970 ↗
• InjuryJun 19, 2023Low impedance; Device Contamination with Chemical or Other Material; Low impedance; Device Contamination with Chemical or Other Material

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT VIA MANUFACTURER REPRESENTATIVE (REP) WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. ON JUNE 6, 2023 THE REP, COVERED A BURIED LEAD TRIAL WITH THE HCP. THE HCP DID A LAMINECTOMY AT T8 AND PLACED THE PADDLE COVERING THE T7/8 VERTEBRAL LEVELS. SHE ANCHORED THE PADDLE AND WANTED 40 CM EXTENSIONS TO TUNNEL TO THE FLANK, WHERE SHE WOULD THEN PROCEED WITH THE BURIED LEAD TRIAL AND CONNECT THE WENS TO THE EXTENSIONS. SHE HAD TO ASK THE SALES REP, FOR 40 CM EXTENSIONS BUT HE ONLY HAD 20 CM ON HAND. THIS CREATED AN ISSUE WHERE THERE WAS NOT ENOUGH EXTENSION TO BE FAR AWAY FROM THE STERILE OPENING. (B)(6) HAD ASKED THE RESIDENT TO PULL THE EXTENSIONS OUT AS FAR AS I CAN LEAVE IN ABOUT, 4 INCHES OF EXTENSION EXPOSED TO CONNECT TO THE WENS. IN ORDER TO KEEP THE AREA STERILE, THEY DID NOT PUT THE WENS IN A BOOT BUT INSTEAD PLACED THE WENS IN THE AREA WHERE THE EXTENSIONS WERE COMING OUT UNDER ONE LARGE TEGADERM. THE PATIENT CONTINUED TO BLEED FROM THE SITE WHERE THE EXTENSIONS WERE COMING OUT AND THIS BLEEDING THEN GOT INTO THE WENS. THIS OCCURRED SOMETIME TUESDAY INTO WEDNESDAY WHERE THE REP GOT THE CALL WEDNESDAY

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Insufficient Information; Urinary Tract Infection

  MAUDE report 17152931 ↗
• MalfunctionJun 16, 2023High impedance; Energy Output Problem; High impedance; Energy Output Problem

  INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE (REP) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT #15 ELECTRODE WAS SHOWING AN IMPEDANCE OF >10,000 WHICH DID NOT ALLOW HIM TO INCREASE HIS AMPLITUDE DURING HIS TRIAL. IMPEDANCES WERE CHECKED. THE REP ALSO INSPECTED THE LEAD IN THE WIRELESS EXTERNAL NEUROSTIMULATOR (WENS), REMOVED IT AND PLACED IT BACK IN THE WENS 3 TIMES. THE REP REPROGRAMMED TO NOT INCLUDE THE USE OF THAT ELECTRODE. ISSUE REMAINS ONGOING AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148215 ↗
• MalfunctionMay 19, 2023High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT WHEN MAPPING THE PATIENT IN THE PROCEDURE ROOM, LEAD CONNECTION WAS CHECKED AND SHOWED "DISCONNECT" ON SEVERAL ELECTRODES EVEN AFTER REMOVING/REPLACING THEM FROM THE ENS. IMPEDANCES WERE LISTED AS 40,000 FOR MULTIPLE ELECTRODES. THE LEADS WERE TESTED WITH ANOTHER ENS AND THE PROBLEM CONTINUED. THEY REMOVED BOTH LEADS AND IMPLANTED NEW LEADS. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16963217 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UN KNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT REP MET WITH PATIENT THIS MORNING TO TURN TRIAL PROGRAMMING TO HD, PER HCP REQUEST. HE ARRIVED AND MENTIONED TO REP IN THE WAITING ROOM THAT HE HAD A FEVER YESTERDAY AND HAD TAKEN TYLENOL THIS MORNING. REP TOLD THE ADMITTING NURSE AND THEY GOT VITALS (ALL WERE NORMAL). WE THEN LOOKED AT THE LEAD INSERTION SITE AND IT HAD PURULENT DRAINAGE, PATIENT REPORTING HE HAS CHANGED THE BANDAGES OFTEN AND THAT HE THOUGHT THIS WAS NORMAL HEALING DRAINAGE. SKIN AROUND THE INSERTION SITE WAS WARM AND RED. IT WAS DECIDED TO PULL THE LEADS. AFTER REMOVAL THERE WAS PURULENT DRAINAGE EXITING THE INSERTION SITE. HE GOT A SCRIPT FOR ANTIBIOTICS.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 16870926 ↗
• InjuryApr 27, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT AND MANUFACTURING REPRESENTATIVE (REP) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT'S TRIAL LEADS WERE CAUSING EXTREME PAIN MIDWAY THROUGH THE TRIAL. REPROGRAMMING WAS ATTEMPTED, AND IMPEDANCES WERE LOW BUT NORMAL. HOWEVER, THE PATIENT HAD PAIN WITH CERTAIN ELECTRODES BEING STIMULATED. THE HCP THINKS THAT THE LEADS SLIPPED OFF TO THE RIGHT GUTTER CAUSING THE PAIN EVEN WITH STIMULATION OFF. THE PATIENT WAS TAKEN TO THE ER VIA AMBULANCE DUE TO SEVERE PAIN, AND THE TRIAL LEADS WERE REMOVED. THE ISSUE WAS RESOLVED. (B)(6) 2023 E1: THE REP PROVIDED THE DEVICE SERIAL NUMBERS.

  Patient problems: Pain

  MAUDE report 16824624 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UN KNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT ON DAY 3 OF THE PATIENT'S TRIAL, THE PATIENT'S SON CALLED LATE AT NIGHT REPORTING PT IN EXTREME PAIN IN BACK, CAN¿T WALK, VOMITING, FEVER, PASSING OUT. THE PATIENT WAS INSTRUCTED TO GO TO ER AND TURN DEVICE OFF. THE PATIENT WAS TAKEN TO THE ER; HOSPITALIZED. ON (B)(6) 2023, THE PATIENT WAS SEEN BY THE HCP, AND THE PATIENT HAD NO FEVER, AND NO SIGN OF INFECTION. THE LEAD WAS REMOVED. THE REP INDICATED THAT THEY WERE UNABLE TO GET CLEAR INFORMATION FROM THE PATIENT, AS THEY HAVE COMPLICATED FAMILY DYNAMICS. IT IS UNKNOWN IF THERE ARE ANY ISSUES WITH THE DEVICE.

  Patient problems: Ambulation or Postural Difficulties; Fever; Loss of consciousness; Pain; Vomiting

  MAUDE report 16726016 ↗
• InjuryApr 5, 2023High impedance; Human-Device Interface Problem; High impedance; Human-Device Interface Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING AN WIRELESS EXTERNAL NEUROSTIMULATOR (WENS) FOR UNKNOWN INDICATIONS FOR USE. THE REASON FOR CALL WAS THE CALLER REPORTED THAT THEY WERE CONDUCTING A PROCEDURE TO PLACE A TRIAL SYSTEM FOR THE PATIENT. THE PHYSICIAN HAD DIFFICULTY IMPLANTING TWO LEADS SO ELECTED TO USE ONE LEAD. WHEN THE LEAD WAS CONNECTED TO THE WENS THEY TESTED IMPEDANCE AND FOUND THAT TWO ELECTRODES DISPLAYED THE RED INDICATOR. THEY WIPED THE LEAD DOWN AND RETESTED BUT THAT DID NOT RESOLVE THE ISSUE. THE CALLER INDICATED THAT THEY CONNECTED THE LEAD TO THE OTHER PORT ON THE WENS AND THEY GOT THE SAME TWO ELECTRODES DISPLAYING RED INDICATORS. THE PHYSICIAN ELECTED TO ABORT THE TRIAL AND EXPLANT THE LEAD. SERIAL NUMBERS AND PATIENT INFORMATION WAS REPORTED. THE CALLER WAS NOT WITH THE PATIENT. THE CALLER INDICATED THAT THEY PLAN TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683270 ↗

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