N/A 9772501Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 00763000586850), received between Jun 11, 2024 and Sep 11, 2026 — classified as 65 injuries, 30 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 95 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 50744410 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Incontinence; Insufficient Information; Pain

  MAUDE report 50740233 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Rep spoke with the patient before the trial to discuss her leg weakness, heaviness, and difficulty walking. The placement proceeded as planned, and the patient was fine in the PACU. During conversation, patient reported experiencing relief. However, due to the ongoing weakness in her leg, the surgeon decided to conclude the trial. Rep has no additional information, and the device was explanted.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Muscle Weakness/Atrophy

  MAUDE report 50733838 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a healthcare professional (HCP) via a manufacturer representative (rep) regarding a patient (pt) with an implanted neurostimulator (INS). It was reported that there was pus at insertion site of trial lead on lead pull date of (b)(6) 2026. HCP prescribed antibiotics after removing leads. The issue is still ongoing. The rep will submit any new information as they become aware.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 50056252 ↗
• InjuryJul 10, 2026Break; Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation

  PATIENT REPORTS THAT HE HAD VERY UNCOMFORTABLE ZAPPING SEVERAL HOURS AFTER RETURNING HOME FROM TRIAL PROCEDURE THAT HE COULD NO LONGER TOLERATE. HE PRESENTED TO THE ER. THE ER PHYSICIAN WAS ADVISED BY THE PAIN PHYSICIAN TO REMOVE LEADS FROM THE WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). PATIENT REPORTS ZAPPING CEASED WHEN THIS WAS DONE. HE REPORTS THAT THE ER DOCTOR BROKE ONE OF THE LEADS. THIS LEAD WAS VISUALIZED IN CLINIC TODAY AND IT DID APPEAR CUT OR BROKEN AT THE PROXIMAL END. THE PORTION WITH THE CONTACTS THAT GO INTO WENS WAS GONE. PATIENT REPORTS SEVERE PAIN WHILE POINTING TO THE AREA WHERE LEADS WERE PLACED. PATIENT REPORTS THAT HE DID NOT CONTACT A MANUFACTURER REPRESENTATIVE (REP). PATIENT REPORTS HE DID NOT USE HIS CONTROLLER TO TURN DOWN THE STIMULATION INTENSITY. IT WAS CONFIRMED THAT THE PAIN PHYSICIAN TOLD THE ER DOCTOR TO REMOVE THE LEADS FROM THE WENS, NO DIRECTION TO CUT OR TUG THE LEADS. PATIENT REPORTS THAT THE ZAPPING OCCURRED IN VARIOUS MOVEMENTS AND POSITIONS. WE DID PUT THE REMAINING LEAD BACK INTO THE WENS TO ASSESS PARESTHESIA COVERAGE. THE REMAINING LEAD COVERED ONLY PATIENTS LEFT BACK AND LEG. PATIENT EXPERIENCING OVERSTIMULATION HOURS AFTER PROGRAMMING

  Patient problems: Device Overstimulation of Tissue; Electric Shock; Pain

  MAUDE report 25786999 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT (PT) HAD DISCOMFORT IN THEIR TOES FOLLOWING TRIAL IMPLANT PROCEDURE. THE PHYSICIAN DECIDED TO REMOVE THE LEADS WITHIN 30 MINUTES OF THE PROCEDURE COMPLETION DUE TO THIS. THE CAUSE IS UNKNOWN, AND IT IS UNKNOWN IF THE ISSUE HAS BEEN RESOLVED. THE LEADS WERE DISCARDED. THE REP PROVIDED THE SERIAL NUMBER OF THE WENS, AND NOTED IT WAS UNKNOWN IF THE ISSUE HAD BEEN RESOLVED BUT THE INFORMATION WAS CONFIRMED WITH THE PHYSICIAN.

  Patient problems: Discomfort

  MAUDE report 25578146 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WITH EXTERNAL NEUROSTIMULATOR (ENS). THE REP REPORTED THAT THE TRIAL LEAD WAS PLACED IN AN AREA OF STENOSIS AND REMOVED DUE TO CHRONIC PAIN AFTER THE PROCEDURE. THE PATIENT HAD CERVICAL STENOSIS PAIN IN HER FEET THAT WAS TRIGGERED DURING LEAD PLACEMENT. THE PAIN DID NOT SUBSIDE SO SHE ELECTED TO GO TO THE HOSPITAL TO RESOLVE THE PAIN. WE TROUBLESHOT BY PULLING LEAD OUT OF THE CERVICAL SPACE INTO THE THORACIC. THE TRIAL LEADS WERE PLACED AND PATIENT CAME OUT TO RECOVERY AND WAS SUFFERING FROM PAIN. PAIN WOULD NOT SUBSIDE, SO HEALTHCARE PROVIDER (HCP) ELECTED TO HAVE THE LEADS EXPLANTED. THE ISSUE HAS BEEN RESOLVED. THE REP WILL SUBMIT ANY NEW INFORMATION AS THEY BECOME AWARE OF IT.

  Patient problems: Pain; Stenosis

  MAUDE report 25408738 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING AN EXTERNAL NEUROSTIMULATOR (ENS) TRIAL. IT WAS REPORTED THE PT HAD A SEVERE CSF HEADACHE FOLLOWING TRIAL, WENT TO EMERGENCY ROOM AND THEY SUSPECTED CSF LEAK. PT WAS SENT HOME AND WAS IMPROVING, WITH RETURN OF SEVERE HEADACHE ON (B)(6) SO PT WENT BACK TO THE ER ON (B)(6) WHERE THEY PULLED THE TRIAL LEAD SO THEY COULD DO A BLOOD PATCH. THE LEAD WAS EXPLANTED AND DISCARDED. THE ISSUE WAS RESOLVED WITH DEVICE REMOVAL, CAUSE UNKNOWN. THE REP NOTED THEY WOULD SUBMIT ANY NEW INFORMATION THAT BECAME AWARE OF.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 25331206 ↗
• MalfunctionMay 1, 2026Failure to Deliver Energy; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS CALLER STATES THAT THE PATIENT STARTED THEIR TRIAL ON TUESDAY AND YESTERDAY WAS A LITTLE SORE BUT TODAY THEY ARE FEELING GOOD WHEN THE THERAPY IS ON. CALLER STATES TODAY THE PATIENT WENT TO CHECK ON THE THERAPY AND IT WAS OFF WHICH WAS UNEXPECTED. CALLER MET WITH THE PT AND THE STIMULATION WAS SHOWING AS OFF. THE HANDSET WAS NOT FINDING THE DEVICE. CALLER SAID THEY HAD TO RECONNECT THE WENS BY PUSHING THE BUTTONS AND IT CONNECTED BUT JUST A LITTLE LATER IT COULDN'T FIND THE WENS AGAIN. IMPEDANCES WERE GOOD TODAY. THE CALLER RE-ALIGNED THE LEAD SLIGHTLY BUT OTHERWISE, EVERYTHING LOOKED GOOD AND THE PT WENT HOME. THE PT CALLED AGAIN SHORTLY THEREAFTER AND IS NOT FINDING THE WENS WITH THE HANDSET AGAIN. CALLER IS GOING TO MEET WITH THE PATIENT TO CHANGE OUT THE WENS AND POSSIBLY THE HANDSET AS WELL. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING.

  Patient problems: Discomfort

  MAUDE report 25056958 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT (PT) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING THE TRIAL PT WITH AN EXTERNAL N EUROSTIMULATOR (ENS). PT REPORTED TO THE REP THAT THEY NOTICED CLEAR BROWN DISCHARGE ON THEIR PAJAMAS FOR "THE LAST FEW DAYS". REP REPORTS NOTIFYING THE PHYSICIAN. NO TROUBLESHOOTING WAS ATTEMPTED, THE CAUSE IS UNKNOWN AND THE ISSUE IS STILL ONGOING. REP REPORTED THAT THE CAUSE WAS UNKNOWN. THE PATIENT WAS SEEN IN THE CLINIC AND LEADS WERE REMOVED. THE ISSUE WAS RESOLVED.

  Patient problems: Fluid Discharge

  MAUDE report 25015477 ↗
• MalfunctionApr 21, 2026High impedance; Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS REP SAID THEY DID A TRIAL ON A PATIENT AND THE PATIENT HAD SOME IMPEDANCES THAT ARE A LITTLE ON THE HIGH SIDE, BUT NOTHING TOO FAR OUT OF THE ORDINARY. REP SAID THEY CANNOT GET THE PATIENT TO THRESHOLD UNLESS THEY BROUGHT THE STIMULATION UP TO LIKE 16-17 MILLION MA, WHICH WAS UNUSUAL. PATIENT DIDN'T FEEL STIMULATION AT THE SITE ITSELF, BUT WHEN THEY GET THAT HIGH, IT WAS ALL DOWN THE RIGHT LEG. REPRESENTATIVE TESTED IMPEDANCE IN PRONE POSITION, WHEN THEY TESTED THE FIRST TIME, SITTING UP THE SECOND TIME. REPRESENTATIVE MENTIONED THAT CONTACT 4, 11, AND 6 HAVE 6,800-7,000OHMS , BUT THEY WERE NOT USING THOSE IN THEIR PROGRAMMING, ALL OTHER ELECTRODES WERE 1000-1300 OHMS. REP TO SEND PATIENT HOME WITH LOWER STIMULATION AND ALLOW PATIENT TO INCREASE STIMULATION, AS NEEDED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. REP ALSO MENTIONED THE POSSIBILITY OF THE LEAD NOT IN THE EPIDURAL SPACE. TECHNICAL SERVICES DIDN'T ASK FOLLOW UP QUESTIONS.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 24944606 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH A TRIAL EXTERNAL NEURO STIMULATOR (ENS). PATIENT WENT TO THE EMERGENCY DEPARTMENT (ED) TO BE CHECKED FOR INCREASING FEVER AND CONCERNED ABOUT A POSSIBLE INFECTION. LEADS WERE ALREADY PULLED BY THE ED. IN ADDITION, ISSUE WAS NOT CONSIDERED A PRODUCT DEFECT SCENARIO. PATIENT REPORTED A FEVER OF 99.3, WASN'T FEELING WELL AND CONCERNED ABOUT POSSIBLE INFECTION. ADMITTED HIMSELF TO THE ED FOR TESTS/OBSERVATIONS. MULTIPLE TESTS RUN BY THE ED TO CHECK FOR CAUSE OF PATIENT NOT FEELING WELL AND POSSIBLE INFECTION. ACCORDING TO PATIENT, TESTS WERE NEGATIVE. NO SIGNS OF INFECTION FOUND. ED PULLED THE LEADS AND PATIENT WAS DISCHARGED. ED PULLED TRIAL LEADS PRIOR TO SCHEDULED LEAD PULL DATE THAT WAS SCHEDULED FOR (B)(6) 2026.

  Patient problems: Fever

  MAUDE report 24900305 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  ON 2026-MAR-11, INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN EXTERNAL NEUROSTIMULATOR. THE REASON FOR CALL WAS CALLER REPORTED THE PATIENT HAD A 977C265 IMPLANTED WITH 2 EXTENSIONS, WITH A LAMINOTOMY, FOR A "OPEN LEAD TRIAL" ON (B)(6). CALLER STATED THE PATIENT WAS DOING GREAT WITH THE TRIAL, HAS HAD SURGICAL PAIN SINCE IMPLANT BUT SINCE LAST NIGHT, THE PATIENT HAS HAD UNBEARABLE MID BACK PAIN WHERE THE INCISION SITE. CALLER MENTIONED THE PATIENT IS CURRENTLY IN THE ER AND THEY ARE ASKING THE CALLER ABOUT ELIGIBILITY FOR X-RAYS, CT SCANS, AND MRIS. AGENT REVIEWED INFORMATION AND REDIRECTED TO HEALTHCARE PROVIDER. 2026-MAR-12: ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE SERIAL NUMBER OF THE LEAD WAS REPORTED. THE HCP BELIEVES THE CAUSE OF THE PATIENT'S UNBEARABLE MID BACK PAIN WAS AN INFECTION THAT IS CAUSING PAIN NEAR THE SURGICAL SITE. THE HCP DID EXPLORATORY SURGERY TODAY AND REOPENED THE POCKET SITE AND SPINAL PADDLE LEAD SURGICAL SITE, AND HE BELIEVES BOTH WERE INFECTED. THE HCP PERFORMED A FULL SYSTEM EXPLANT, INCLUDING THE LEAD AND BOTH EXTENSIONS. THE PATIENT UNDERWENT WOUND IRRIGATION AND SENT CULTU

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24676455 ↗
• InjuryMar 10, 2026Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). REP PROVIDED THE SERIAL NUMBER FOR THE TRIAL STIMULATOR. REP SUSPECTED THE LEAD FRACTURE WAS DUE TO HOW IT WAS TAPED. REP SAID THEY HAVE THE DEVICE AND WAS WAITING ON A RETURN MAILER KIT FOR IT WILL BE RETURNED. THE INFORMATION WAS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558276 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE REGARDING AN EXTERNAL NEUROSTIMULATOR NEUROSTIMULATOR. THE REASON FOR CALL WAS CALLER REPORTS PATIENT STARTED A TRIAL TODAY AND IS REPORTING PAIN DOWN THE RIGHT SIDE OF THE LEG "OUTSIDE OF NORMAL". CALLER IS INQUIRING IF PATIENT CAN HAVE AN MRI AND REPORTS PATIENT HAS 2 OF THE 977A260 LEADS IMPLANTED CONNECTED TO TWO EXTENSIONS THAT ARE PARTIALLY EXTERNALIZED. AGENT REVIEWED MRI IS NOT RECOMMENDED DURING TRIAL AND WITH COMPONENTS PARTIALLY OUTSIDE THE BODY. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP) WHO REPORTED THE CAUSE OF THE PAIN WAS UNABLE TO BE DETERMINED. THEY REPORTED PATIENT CAME OUT OF SURGERY IN SIGNIFICANT PAIN AND THE SURGEON ORDERED AN MRI HOWEVER, RESULTS WERE UNABLE TO BE CONCLUDED. THE REP STATED THE IMPEDANCES WERE WITHIN NORMAL LIMITS AND PATIENT'S PAIN WAS CONSISTENT WHETHER STIMULATION WAS ON OR OFF. THE PATIENT IS CURRENTLY ADMITTED IN THE HOSPITAL AND AWAITING TO UNDERGO ANOTHER MRI UNDER ANESTHESIA. THE REP REPORTED THE DEVICES WERE REMOVED AND DISCARDED BY THE HOSPITAL IN ORDER FOR PATIENT TO HAVE THE MRI.

  Patient problems: Pain

  MAUDE report 24546597 ↗
• InjuryMar 2, 2026Impedance Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE REGARDING A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). THE REASON FOR CALL WAS CALLER REPORTS THEY ARE IN THE OR AND ARE HAVING DIFFICULTY WITH THE WENS. CALLER STATES THEY GOT A NEW WENS AND THEY ARE STILL HAVING CONNECTIVITY ISSUES. CALLER REPORTS WHEN THEY DID A CONNECTIVITY CHECK, THEY ALL WENT OUT ON THE ONE LEAD, LATER STATING BOTH LEADS, EXCEPT FOR 14 AND 15. CALLER STATED THEY SWITCHED THE LEADS AND ARE STILL RUNNING INTO ISSUES. AGENT ASKED IF THERE IS ANY FLUID ON THE LEAD AND CALLER STATES NO, THEY HAVE WIPED THE LEADS DOWN MULTIPLE TIMES. CALLER NOTED THEY ARE SEEING AN EXCLAMATION POINT ON CONTACTS 8/9/10, 0-6 ARE OK AND 7 IS OUT. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. REP PLANS TO TRY A DIFFERENT LEAD. REP REPORTED THAT USING THE NEW WENS AND 1 NEW LEAD, THEY WERE ABLE TO GET CLEARED CONNECTIONS AND IMPEDANCE CHECK WAS ALL GREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483106 ↗
• InjuryFeb 25, 2026High impedance

  2026-JAN-28: INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT. THE REP REPORTED THAT A TRIAL WAS ATTEMPTED TODAY BUT WAS EVENTUALLY ABORTED DUE TO THE ISSUES NOTED. THE REP STATES THEY GOT THE INITIAL LEAD IN PLACE AND CONNECTED TO THE WIRELESS EXTERNAL NEURO STIMULATOR (WENS). THE REP SAID THE 'WIRING OF THE LEAD TO THE WENS WAS NOT ABLE TO GET A POSITIVE CONNECTION' ON LEAD SELECT SCREEN AND SHOWED AN ALERT TO THE EFFECT OF 'LEAD NOT PROPERLY CONNECTED, TRY AGAIN'. THE REP WAS ABLE TO GET TO THE CHECK CONNECTIVITY SCREEN WHERE SOME OF THE CONTACTS WERE SHOWING AN ISSUE. THE REP WENT ON TO NOTE THAT IMPEDANCE TEST SHOWED SOME CONTACTS >40K. THE REP SWAPPED THE LEAD IN THE WENS PORT AND THE SAME ISSUE OCCURRED WITH SAME CONTACTS COMPROMISED. THEY THEN SWAPPED THE LEAD AND THE SAME ISSUE OCCURRED. THEY THEN SWAPPED THE WENS AND THE SAME ISSUE OCCURRED. THEY THEN TRIED ANOTHER TABLET AND THE SAME ISSUE OCCURRED. REP TO SEND PRODUCTS BACK. 2026-JAN-30: ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THEY BELIEVE THEY MAY HAVE AN ANSWER FOR WHAT HAPPENED DURING THE TRIAL: THE PATIENT'S EPIDU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444687 ↗
• InjuryFeb 25, 2026High impedance

  ON 2026-JAN-28: INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT. THE REP REPORTED THAT A TRIAL WAS ATTEMPTED TODAY BUT WAS EVENTUALLY ABORTED DUE TO THE ISSUES NOTED. THE REP STATES THEY GOT THE INITIAL LEAD IN PLACE AND CONNECTED TO THE WIRELESS EXTERNAL NEURO STIMULATOR (WENS). THE REP SAID THE 'WIRING OF THE LEAD TO THE WENS WAS NOT ABLE TO GET A POSITIVE CONNECTION' ON LEAD SELECT SCREEN AND SHOWED AN ALERT TO THE EFFECT OF 'LEAD NOT PROPERLY CONNECTED, TRY AGAIN'. THE REP WAS ABLE TO GET TO THE CHECK CONNECTIVITY SCREEN WHERE SOME OF THE CONTACTS WERE SHOWING AN ISSUE. THE REP WENT ON TO NOTE THAT IMPEDANCE TEST SHOWED SOME CONTACTS >40K. THE REP SWAPPED THE LEAD IN THE WENS PORT AND THE SAME ISSUE OCCURRED WITH SAME CONTACTS COMPROMISED. THEY THEN SWAPPED THE LEAD AND THE SAME ISSUE OCCURRED. THEY THEN SWAPPED THE WENS AND THE SAME ISSUE OCCURRED. THEY THEN TRIED ANOTHER TABLET AND THE SAME ISSUE OCCURRED. REP TO SEND PRODUCTS BACK. ON 2026-JAN-30: ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THEY BELIEVE THEY MAY HAVE AN ANSWER FOR WHAT HAPPENED DURING THE TRIAL: THE PATIENT'S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444672 ↗
• MalfunctionJan 27, 2026Failure to Interrogate; Migration or Expulsion of Device; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT REGARDING AN EXTERNAL NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT REPORTED THEY STARTED THE TRIAL LAST MONDAY AND WHEN THEY WENT IN TO GET POTENTIALLY TAKEN OUT TODAY, THE LEADS HAD DROPPED A LOT. PATIENT STATED THEIR REPRESENTATIVE (REP) PROGRAMMED IT THIS MORNING FOR IT TO GO A COUPLE MORE DAYS LONGER AND NOW THEIR BACK WAS BURNING AND THEY COULDN'T CONNECT TO THE STIMULATOR TO TURN IT OFF. PATIENT REPORTED WHEN THEY GO TO THE APP, THEY CLICK CONNECT AND IT JUST DOES THE CONNECTING FOR A WHILE AND THEN IT JUST STATED NOT FOUND. PATIENT TRIED RESTARTING THE HANDSET, BUT DID NOT RESOLVE. PATIENT STATED THEY DIDN'T SEE A LIGHT ON THE WENS BUT WASN'T SURE. AGENT REDIRECTED TO THEIR HEALTHCARE PROVIDER/LOCAL REPS TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Burning Sensation

  MAUDE report 24190713 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) STATING THE PATIENT WAS HOSPITALIZED WITH THE FLU DURING THEIR TRIAL. CAUSE OF THIS WAS UNKNOWN. THE LEADS WERE PULLED BY THE HEALTHCARE PROVIDER (HCP) ENDING THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190011 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT DUAL TRIAL FOR SPINAL CORD STIMULATION, THE TRIAL WAS PERFORMED UNDER LOCAL ONLY, LEADS WERE PLACED AT T7 AND PATIENT WAS TESTED ON THE TABLE WITH 450PW/50HZ AND CAPTURED COVERAGE AT 11MA. POST OP PATIENT WAS IN PAIN, WAS ADMINISTER DRUGS TO HELP WITH PAIN, AS TIME WENT ON THE PHYSICIAN REMOVED BOTH LEADS. IT WAS NOTED THE PATIENT EXPERIENCED AN EPIDURAL HEMATOMA, WHICH REQUIRED SURGERY AND RESULTED IN HOSPITALIZATION. THE PATIENT WAS TRANSFERRED FROM AN AMBULATORY SURGERY CENTER TO A HOSPITAL, AND SUBSEQUENTLY TO A LARGER HOSPITAL, WHERE AN INTENSIVE CARE UNIT VISIT OCCURRED. THE PATIENT WAS REPORTED TO BE ALIVE WITH INJURY.

  Patient problems: Hematoma; Pain

  MAUDE report 24177601 ↗
• MalfunctionJan 15, 2026Appropriate Device Problem Term/Code Not Available

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) VIA A PATIENT REGARDING AN WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). THE REASON FOR CALL WAS THE PATIENT CLAIMED THAT OVERNIGHT THE WENS STARTED MAKING A BEEPING NOISE. THE CALLER WAS NOT WITH THE PATIENT. TECHNICAL SERVICES REVIEWED THAT THE DEVICE DOESN'T HAVE A MECHANISM TO MAKE NOISES AND THE WENS COULD BE SENT IN FOR ANALYSIS. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082407 ↗
• InjuryDec 8, 2025High impedance; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE CAUSE WAS ANATOMICAL/POSITIONAL. IT WAS CORRECTED AFTER PATIENT SAT UP. THE REP SAID THE DEVICE WILL NOT BE RETURNED BECAUSE THE ISSUE WAS CORRECTED AND TRIAL WAS SUCCESSFUL. THE REP PROVIDED THE PATIENT (PT) INFORMATION AND SERIAL NUMBERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743870 ↗
• MalfunctionDec 4, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE DEVICE IN QUESTION WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715906 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED REGARDING AN IMPLANTABLE DEVICE. IT WAS REPORTED THAT THE PATIENT (PT) COMPLAINED OF PAIN IN THE PACU BUT THE DOCTOR EXAMINED THEM AND STATED IT WAS JUST PROCEDURAL. THE PATIENT CALLED THE MANUFACTURER REPRESENTATIVE (REP) THE FOLLOWING NIGHT (11/28), STATED THEY WERE IN EXTREME PAIN AND HAD PRESSURE FROM HIS SHOULDER BLADES TO THE BACK OF HIS HEAD AND COULD BARELY MOVE THEIR NECK. THE PT HAD A THORACIC LEAD PLACEMENT AT T8 AND T9 FOR LUMBAR PAIN. THE REP REACHED OUT TO THE PHYSICIAN AND INSTRUCTED THE PT TO CALL THE ON CALL DOCTOR OR GO TO THE ER. THE PT WENT TO THE ER THE NEXT MORNING (11/29). PT WAS ADMITTED AND ASKED BY THE ON CALL DOCTOR TO TURN THE STIM BACK ON. THE PT REFUSED AND WANTED THE LEADS REMOVED. THE FOLLOWING MORNING (11/30) THE LEADS WERE REMOVED AND DISCARDED, AND THE PHYSICIAN IN THE ROOM CONFIRMED THE PT HAD A CSF LEAK. THE WIFE OF THE PT FILLED IN THE REP ON ALL DETAILS THAT DAY (11/30), THE REP WAS NOT PRESENT FOR ANY OF THESE INTERACTIONS. THE PT WAS SCHEDULED FOR A BLOOD PATCH THE NEXT DAY (11/31). THE PT DID NOT WANT TO MOVE FORWARD TO IMPLANT AT THAT TIME SINCE THEY WERE NOT ABLE THE TELL THE EFFICIENCY OF THE DEVICE DUE TO THE CS

  Patient problems: Ambulation or Postural Difficulties; Cerebrospinal Fluid Leakage; Discomfort; Pain

  MAUDE report 23684222 ↗

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