Verify™ 353101 (UDI 00763000879280)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00763000879280), received between Aug 9, 2024 and Sep 23, 2026 — classified as 11 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (9 reports).

7 other recalls cover devices cleared under the same FDA submission (P080025, P970004); 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 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, information was received from a manufacturer representative and patient regarding a trial patient who was using an external neurostimulator (ENS) for Urgency Frequency and Urge Incontinence. It was reported that the trial was initiated on (b)(6)2026. It was reported that yesterday they started to have a presumed potential allergic reaction. The caller was not with the patient at the time of the call, but stated the patient called them last night and reported the issue. Agent sent the caller the spec sheets for the lead and extension to caller. The patient (Pt) to follow up with managing healthcare provider (HCP). Additional information was received from the patient on (b)(6). The patient stated that they had a rash ever since the procedure. It was unknown if the issue was resolved. On (b)(6) 2026, additional information was received from the patient. It was reported that they were itchy and they had papular rash along their lower back and lead insertion site. They removed the lead and percutaneous extension. The issue was resolved.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Rash

  MAUDE report 50866092 ↗
• InjurySep 1, 2026Break; Difficult to Remove

  Information was received from a manufacturer representative regarding a trial patient who was using an external neurostimulator (ENS) for unknown indications for use. The trial began on 2026-Jul-07. It was reported that  the patient cut their leads so they were still implanted. The caller clarified that this account performed the trial for three days and sends instructions home with the patient for them to remove their own leads. The caller stated patient wasn't able to get their leads out so they cut them. The caller stated the physician took the patient back to the OR for permanent implant today and tried to see if they could find the remaining portions of basic evaluation leads but was not able to visualize them in the procedure and wasn't going to perform further surgery in an attempt to locate them. Caller stated physician performed imaging and was able to see the remains on an AP view but not on a lateral view. Therefore, the physician had no indication of how deep the lead remnants were but confirmed they were still implanted. Agent reviewed MRI information from  manual which stated patient should not be exposed to MRI during test stim. Agent and caller discussed programming

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50536823 ↗
• MalfunctionMay 25, 2026Difficult to Insert

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. THEIR TRIAL STARTED ON (B)(6) 2026. IT WAS REPORTED THAT THE TRIAL LEAD WOULD NOT ADVANCE WITH STYLET. THE PHYSICIAN WAS UNABLE TO ADVANCE THE TRIAL LEAD INTO THE NEEDLE HUB. THE STYLET KEPT SLIDING THROUGH THE ELECTRODE END OF LEAD CREATING NO STRUCTURE TO BE ABLE TO INSERT TRIAL LEAD INTO NEEDLE HUB. THE PHYSICIAN WAS UNABLE TO INSERT LEAD PROPERLY INTO 3.5 FORAMEN NEEDLE. THEY HAD TO GET ANOTHER TRIAL LEAD TO USE. THEY HAD NO ISSUES ADVANCING NEW TRIAL LEAD. TROUBLESHOOTING WAS PERFORMED BY ADJUSTING THE STYLET SEVERAL TIMES, AND ATTEMPTING REINSERTION BUT THE LEAD KEPT SLIDING OFF THE STYLET. THE CAUSE OF THE ISSUE WAS UNKNOWN. THE MANUFACTURING REPRESENTATIVE (REP) INDICATED THE STYLET KEPT COMING OUT, SO THEY HAD TO USE ANOTHER LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25267871 ↗
• MalfunctionMay 19, 2026Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM THE PATIENT (PT) REGARDING A TRIAL EXTERNAL NEUROSTIMULATOR (ENS). THE REASON FOR THE CALL WAS THE PATIENT REPORTED THAT LAST NIGHT, AFTER THEY GOT HOME FROM THE HCP'S OFFICE, THEY WERE TRYING TO GET OUT OF THE RECLINER CHAIR, THEY FELT A STRONG TUG ON THE WIRES (REFERRING TO THE LEAD), AND THEY FELT A LOCALIZED PAIN ON THE WIRE, AND ADDED THAT IT'S SORE ON THE LEFT SIDE. AGENT REDIRECTED THEM TO THE HCP TO HAVE THE DEVICE CHECKED, BUT THE PATIENT KEEP ON INSISTING TO JUST HAVE IT CHECKED BY ADJUSTING THE THERAPY SETTING, STATING THAT IF THEY FELT THE STIMULATION ON THE RIGHT SPOT, THEN THE "WIRES" PROBABLY IS JUST FINE. PATIENT MENTIONED THAT THEY WERE SUPPOSED TO INCREASE THE STIMULATION ON THE RIGHT SIDE, WHICH THEY WERE ABLE TO DO LAST NIGHT, AND THEY FELT THE SENSATION ON THE RIGHT SPOT, BUT WHAT THEY ARE WORRIED WAS THE LEFT SIDE, BECAUSE THERE'S WHERE THEY FEEL LIKE THE LEAD GOT DISLODGED. PATIENT WANTED TO SHIFT THERAPY ON THE LEFT SIDE TO CHECK IF THEY WOULD FEEL THE STIMULATION, BUT THEY ADDED THAT THEY WERE SPECIFICALLY TOLD BY THE HCP TO NOT SHIFT SIDES. AGENT REVIEWED THAT PATIENT AND TECHNICAL SERVICES (PATS) CAN WALK THEM THROUGH WITH TH

  Patient problems: Discomfort; Pain

  MAUDE report 25219429 ↗
• MalfunctionMay 5, 2026Failure to Deliver Energy; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGENCY FREQUENCY. IT WAS REPORTED THAT THE TRIAL WAS INITIATED ON (B)(6) 2026 IT WAS REPORTED THAT THE LEADS HAD COME LOOSE RESULTING TO SEEING ERROR MESSAGE "COMMUNICATION ERROR: NO LEADS ATTACHED. SERIAL NUMBER (B)(6)". THEY TAPPED RETRY BUT SAME ERROR SHOWED. THE PATIENT EXPERIENCING LOSS OF STIMULATION AND LOSS OF THERAPY AS ISSUES RELATED TO THE MIGRATION. THE PATIENT WAS ADVISED TO CONTACT CLINICIAN. THEY ALSO MENTIONED PATIENT'S FOOT WENT NUMB LAST (B)(6) 2026. THE EVENT WAS NOTIFIED TO MANUFACTURER REPRESENTATIVE (REP). THE ISSUE WAS NOT RESOLVED AND IT WAS STILL ONGOING.

  Patient problems: Insufficient Information; Numbness

  MAUDE report 25076998 ↗
• MalfunctionApr 14, 2026Break; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. THEIR TRIAL STARTED ON (B)(6) 2026. IT WAS REPORTED THAT THE WIRE DETACHED. THERE WAS MIGRATION/LEAD MOVED/WIRE MOVED. IT WAS UNKNOWN WHETHER THERE A CONNECTOR MIGRATION. IT WAS UNKNOWN WHETHER THE PRODUCT MIGRATE AROUND OR ENTANGLE INTERNAL ORGANS. PATIENT MENTIONED THE WIRES WERE PULLED BUT NO BLEEDING. THERE WAS BROKEN LEAD/LEAD DAMAGED/LEAD CUT. THE CAUSE OF THE ISSUE WAS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. THE ISSUE WAS NOT RESOLVED AND WAS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24869543 ↗
• MalfunctionFeb 27, 2026Failure to Interrogate; Migration or Expulsion of Device; Battery Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT (PT) WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR NON-OBSTRUCTIVE URINARY RETENTION. THE TRIAL BEGAN ON 2026-FEB-11 IT WAS REPORTED THAT THEY HAD COMMUNICATION ISSUE BETWEEN CONTROLLER AND ENS, UNABLE TO COMMUNICATE/CONNECT TO CONTROLLER. THERE WAS NO COMMUNICATION/COULDN'T COMMUNICATE. TROUBLESHOOTING WAS PERFORMED. PT CAME INTO THE OFFICE TO SEE NURSE PRACTITIONER (NP) FOR LEAD PULL FEB/17. THEY HAD NOT SEEN IMPROVEMENT IN SYMPTOMS. NP OPENED THE SMART PROGRAMMER WHICH GAVE COMMUNICATION ERROR: EXTERNAL DEVICE BATTERY HAS DEPLETED. LAST COMMUNICATION WITH PATIENT SHOWED THEY WERE ON LEFT LEAD, 0.9MA AND RATE OF 30 (PHYSICIAN REQUEST DUE TO HISTORY (HX) OF RETENTION). THE CAUSE WAS NOT KNOWN. THE ISSUE WAS RESOLVED. PATIENT EXPERIENCED MIXED RESULTS DURING THE TRIAL. NP WAS UNSURE AT WHAT POINT THE ENS DEPLETED. PT WOULD RETURN TO THE OFFICE IN 1 MONTH TO DISCUSS THE ADVANCED EVALUATION VS IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Urinary Retention

  MAUDE report 24466384 ↗
• MalfunctionFeb 24, 2026Overheating of Device; Adverse Event Without Identified Device or Use Problem

  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 UNKNOWN WHEN THE TRIAL WAS INITIATED. IT WAS REPORTED THAT ON 2026-FEB-12 THE LEAD WAS SCRAPPED AND REPORTED BOWEL LEAKAGE AND BURNED. THEY REPORTED LEAKS, CONSTANT MUCOUS, BROWN MODERATE AND PAD. THE LEAD WAS BURNED.

  Patient problems: Burning Sensation; Fecal Incontinence; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433393 ↗
• MalfunctionFeb 9, 2026Migration or Expulsion of Device

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP). WHEN THE HCP WAS ASKED TO PROVIDE THE STEPS TAKEN TO RESOLVE THE WIRES BEING PULLED OUT, THE HCP STATED THAT THE PATIENT HAD STAGE 2 PROCEDURE SCHEDULED ON (B)(6) 2026. THE HCP STATED THAT THE ISSUE WAS NOT YET RESOLVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24289824 ↗
• InjuryDec 2, 2025Adverse 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 URGENCY FREQUENCY. THE TRIAL BEGAN ON (B)(6) 2025. IT WAS REPORTED THAT THEY HAD SUSPECTED INFECTION AND THERE WERE NO ADDITIONAL SYMPTOMS REPORTED. THE ISSUE WAS NOT RESOLVED AND WAS STILL ONGOING. THE PATIENT WAS HOSPITALIZED AND THE PATIENT WAS ON THE WAY TO THE HOSPITAL TODAY ON (B)(6) 2025. ON (B)(6) PATIENT REPORTED THAT THEY HAD INFECTION AND IN A HURRY TO THE HOSPITAL TODAY. ADVISED TO CONTACT THEIR DOCTOR, IF SYMPTOMS PERSISTED.

  Patient problems: Unspecified Infection

  MAUDE report 23694141 ↗
• MalfunctionNov 7, 2025Break; Difficult to Insert; Break; Difficult to Insert

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS UNKNOWN WHEN THE TRIAL WAS INITIATED. IT WAS REPORTED THAT THE LEAD GUIDE WIRE BROKE THROUGH COIL. THE LEAD WAS OPENED BUT UPON DISCOVERY OF THE ISSUE IT WAS SET ASIDE AND NOT USED. IT WAS UNKNOWN IF THE TROUBLESHOOTING WAS PERFORMED. THE CAUSE OF THE EVENT WAS NOT KNOWN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). WHEN THE REP WAS ASKED TO CLARIFY THE STATEMENT THAT THE LEAD GUIDE WIRE BROKE THROUGH COIL. THE REP STATED THAT THE COIL WAS OUTSIDE OF THE GUIDEWIRE AND WAS UNABLE TO BE THREADED BACK ON. THE REP STATED THAT THE CAUSE OF THE LEAD GUIDE WIRE BROKE THROUGH THE COIL WAS NOT DETERMINED. THE MOST LIKELY CAUSE OF THE EVENT WAS DUE TO THE PRODUCTION OF LEAD. WHEN ASKED ABOUT THE STEPS TAKEN TO RESOLVE THE ISSUE, THE REP STATED THAT THEY BROUGHT THE DOCTOR A NEW BASIC LEAD AND SENT IN THE BROKEN ONE TO DETERMINE. THE REP STATED THAT THE ISSUE WAS RESOLVED AND THEY GAVE THE DOCTOR A NEW LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494308 ↗
• MalfunctionOct 24, 2025Display or Visual Feedback Problem; Failure to Interrogate; Communication or Transmission Problem; Insufficient Device Problem Information; Display or Visual Feedback Problem; Failure to Interrogate; Communication or Transmission Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS UNKNOWN WHEN THE PATIENT'S TRIAL BEGAN. IT WAS REPORTED THAT THEY WENT TO THEIR HEALTHCARE PROVIDER TODAY FOR A FOLLOW-UP APPOINTMENT AND THEY CHANGED THE AAAA BATTERIES IN THE IMPLANT BECAUSE IT WASN'T WORKING. PATIENT SAID WHEN THEY GOT HOME, THEY SAW A SYSTEM ERROR MESSAGE THAT SAID THERAPY MAY HAVE STOPPED AND TO CONTACT THEIR CLINICIAN. PATIENT ALSO SAW AN ERROR MESSAGE SAYING UNABLE TO COMMUNICATE WITH DEVICE, COMMUNICATION LOST, ENSURE EXTERNAL DEVICE IS WITHIN RANGE AND BATTERIES ARE IN PLACE, PRESS THE BUTTON ON THE EXTERNAL DEVICE IF YOU ARE STILL NOT CONNECTING TO DEVICE. PATIENT TRIED TO TROUBLESHOOT WITH THEIR NEIGHBOR, BUT THAT DIDN'T RESOLVE THE ISSUE. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. AGENT REVIEWED MEANING OF MESSAGES AND REVIEWED THAT AAAA BATTERIES ARE LIKELY DEPLETED. THE PATIENT WAS REDIRECTED TO THEIR HEALTH CARE PROVIDER TO FURTHER ADDRESS THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THE LIKELY CAUSE WAS UNKNOWN. THEY HAVE THE IMPLANTED DEVICE AND IT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23385234 ↗
• MalfunctionOct 15, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE TRIAL WAS INITIATED ON (B)(6) 2025. IT WAS REPORTED THAT THEY WERE GETTING A MESSAGE ON THE PROGRAMMER THAT THERE WERE NO LEADS ATTACHED TO THE CABLE. CALLER CONFIRMED THE CABLE WAS PLUGGED INTO THE SIDE OF THE ENS BUT THE ERROR MESSAGE STILL PERSISTED. CALLER MENTIONED THEY COULD PREVIOUSLY SEE A LITTLE THIN WIRE THAT THEY CAN NO LONGER LOCATE AND NOTED THAT THERE WAS A LOT OF TAPE PRESENT AT THE TRIAL SITE. THE ERROR MESSAGE STARTED INTERMITTENTLY ON FRIDAY BUT OCCURRED AGAIN YESTERDAY AND WHEN THEY SPOKE WITH MANUFACTURER REPRESENTATIVE (REP) THEY SAID THAT IT MIGHT HAVE BEEN CAUSED BY THE PATIENT'S BODILY POSITION. THE PATIENT WAS REDIRECTED TO MANAGING HEALTHCARE PROVIDER (HCP) AND RECOMMENDED LETTING REP KNOW AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23277347 ↗
• InjurySep 19, 2025Adverse 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 URGENCY FREQUENCY. THE TRIAL BEGAN ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DEVICE SITE INFECTION (INCISION, POCKET, ETC) AND THERE WERE NO ADDITIONAL SYMPTOMS REPORTED. THE ISSUE WAS NOT RESOLVED AND WAS STILL ONGOING. ON (B)(6), AS PER PATIENT THEY WERE HAVING ITCHYNESS WHERE THE TAPE WAS PLACED, BUT THERE WAS NO SORENESS OR IRRITATION, JUST ITCHYNESS. ADVISED TO CONTACT THEIR DOCTOR, IF SYMPTOMS PERSISTED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 23093839 ↗
• MalfunctionAug 12, 2025High impedance; Adverse Event Without Identified Device or Use Problem; High impedance; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THEY BELIEVE THE CAUSE OF THE ISSUE WAS A BAD CORD CONNECTING THE ENS TO THE LEADS BECAUSE WHEN THEY SWITCHED THAT OUT IT WORKED. THE PHYSICIAN HAD NO FURTHER INFORMATION. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783478 ↗
• MalfunctionMay 13, 2025Impedance Problem; Impedance Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP). THEY REPORTED THAT PATIENT WENT ON FOR THEIR STAGE 2 PROCEDURE. POST IMPLANT, PRIOR TO SUTURING THE POCKET. IMPEDANCE CHECK WAS DONE AGAIN AND ALL 4 ELECTRODE WHERE IN THE GREEN. NO IMPEDANCE ISSUE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013950 ↗
• MalfunctionMar 25, 2025Difficult to Insert; Material Perforation; Difficult to Insert; Material Perforation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URGENCY FREQUENCY. IT WAS REPORTED THAT THE STYLET WAS COMING OUT OF THE SIDE OF THE LEAD. THE HCP WAS UNABLE TO RESET THE STYLET. THE HCP STATED THEY TRIED TO PUT THE STYLET BACK AND REINSERT IT, BUT IT WOULD NOT ALIGN PROPERLY. THE CAUSE OF THE ISSUE WAS NOT KNOWN. THE ISSUE HAD BEEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692015 ↗
• MalfunctionFeb 4, 2025Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS UNKNOWN WHEN THE TRIAL STARTED. IT WAS REPORTED THAT WHENEVER THEY SIT DOWN, THEY CAN FEEL THE LEADS PUSHING IN, WHICH CAUSE SLIGHT DISCOMFORT. HOWEVER, THEY DO NOT FEEL IT WHEN STANDING. THEY ALSO STATED THAT THE DISCOMFORT WAS TOLERABLE. IT WAS UNKNOWN WHETHER THE ISSUE WAS RESOLVED.

  Patient problems: Discomfort

  MAUDE report 21301329 ↗
• InjuryJan 30, 2025Migration or Expulsion of Device; Energy Output Problem; Therapeutic or Diagnostic Output Failure; Migration or Expulsion of Device; Energy Output Problem; Therapeutic or Diagnostic Output Failure

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT YESTERDAY THEY GOT A MESSAGE ON THEIR HANDSET THAT SAID, "THE SYSTEM IS OPERATING AT MAXIMUM SETTINGS AND THERAPY CANNOT BE INCREASED." THEY STATED THEY HIT MAX SETTINGS AT 1.1 MA ON THE LEFT SIDE AND AT 1.5 MA OR 2.0 MA ON RIGHT SIDE. AT ONE POINT AFTER INITIALLY ENCOUNTERING THE MESSAGE, THEY SAID THEY WERE ABLE TO INCREASE TO 3.8 MA. WHILE ON THE CALL, PATIENT HAD DECREASED THERAPY FROM 1.1 MA TO 0.9 MA AND WHEN THEY TRIED TO INCREASE BACK UP TO 1.1 MA, THEY GOT THE MESSAGE AGAIN AND WERE THEN UNABLE TO INCREASE FROM 0.9 MA. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. THE MANUFACTURING REPRESENTATIVE (REP) WAS ALSO CONTACTED ABOUT THE SITUATION AND THEY INDICATED THEY HAD SPOKEN WITH THE PATIENT.ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) ON 2025. THE REP REPORTED THAT THE CAUSE WAS NOT CONFIRMED AND THAT THE LEAD LIKELY MIGRATED OR NOT IN THE CORRECT LOCATION. THEY FOUND COMFORTABLE STIMULATION ON OPPOSITE L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273025 ↗
• InjuryJan 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION (INCONTINENCE, URGENCY, AND/OR FREQUENCY) Y. IT WAS REPORTED THAT LEAD FRACTURED, DAMAGED, OR BROKEN (DO NOT SELECT FOR IMPEDANCE ISSUES IF NO PHYSICAL DAMAGE. LEAD HEAD BROKEN. SPLIT INTO 2 SECTION. 0-1 AND 2-3 WAS OBSERVED. THE DEVICE REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231346 ↗
• MalfunctionOct 4, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGENCY FREQUENCY. THEIR TRIAL STARTED ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON (B)(6) 2024 STATING THAT THE LEADS HAVE DISLODGED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 2024-SEP-11 STATING THAT THEIR DEVICE WAS REMOVED EARLY AS A RESULT OF THE LEADS BECOMING DISLODGED AND UNABLE TO RECONNECT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) STATING THAT THE PATIENT HAD THEIR POST OP APPOINTMENT ON (B)(6) 2024 AND WENT HOME AND HAS NOT BEEN SEEN SINCE THEN. THE PATIENT DOES NOT WANT TO PROCEED WITH STAGE 2 TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20375645 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP). THE HCP STATED THAT THE PATIENT EXPERIENCED HIGH BLOOD PRESSURE AND LOW OXYGEN LEVEL AFTER PROCEDURE. THE HCP CONFIRMED THAT THE HOSPITALIZATION WAS NOT DUE TO THE DEVICE OR THERAPY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP). HCP STATED THAT THE PATIENT WAS HOSPITALIZED DUE TO HIGH BLOOD PRESSURE AND LOW OXYGEN LEVELS. THEY FURTHER CLARIFIED THAT THE HIGH BLOOD PRESSURE AND THE LOW OXYGEN LEVELS WERE NOT RELATED TO THE DEVICE OR THERAPY. THIS EVENT IS NO LONGER A REPORTABLE EVENT. MDR DECISION CORRECTED TOO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL MDRS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED MAKES THE EVENT REPORTABLE. DUE TO GCH FUNCTIONALITY, THE COMPLAINT FLAG CANNOT BE FLIPPED TO 'NO' AS A REGULATORY REPORT EXISTS IN THIS PE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20264721 ↗
• MalfunctionSep 18, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) REGARDING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN USE FOR INDICATION. IT WAS REPORTED THAT WHILE THE PATIENT WERE GOING/TRYING TO INSERT THE LEAD INTO THE FORAMEN NEEDLE THEY DISCOVERED IT WAS BENT. TROUBLESHOOTING WAS PERFORMED. THEY REPORTED THAT THEY EVALUATED THE LEAD. THE CAUSE WAS NOT KNOWN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT NO ONE COULD SAY IF THE LEAD CAME OUT OF THE BOX BENT. IT WAS NOTICED WHILE TRYING TO INSERT IT INTO THE FORAMEN NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250921 ↗
• MalfunctionSep 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM AN MANUFACTURING REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URINARY DYSFUNCTION (INCONTINENCE, URGENCY, AND/OR FREQUENCY). IT WAS REPORTED THAT THE SURGEON REQUESTED A NEW LEAD DURING THE PROCEDURE DUE TO THE LEAD NOT GETTING A RESPONSE FROM THE PATIENT WHEN IT WAS TESTED PRIOR TO DEPLOYING THE TINES. THEY BELIEVED THERE MAY HAVE BEEN A FAULT IN THE LEAD BECAUSE THE PATIENT HAD RESPONDED WHEN THE NEEDLE WAS TESTED. THEY USED A NEW LEAD. THE CAUSE WAS UNKNOWN, BUT USING THE NEW LEAD RESOLVED THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 20246582 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE. THE TRIAL STARTED ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT HAD PAIN AND DISCOMFORT/SORENESS/PINCHING. PATIENT HAD THE TRIAL SYSTEM REMOVED AND NEW LEAD AND BATTERY PLACED VIA REVISION ON (B)(6) 2024. THE PROCEDURE WAS SUCCESSFUL AND THE ISSUE WAS CONFIRMED RESOLVED.

  Patient problems: Discomfort; Pain

  MAUDE report 20245302 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P080025, P970004. One submission often covers many models, so check the product and lot details in each record.

• Z-1704-2025 · Apr 3, 2025 · Open, Classified
  Enhanced Verify Evaluation Handset (CFN HH90130FA)
• 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-2365-2023 · Jul 6, 2023 · Open, Classified
  Medtronic InterStim Ground Pad REF 041826
• Z-0998-2022 · Feb 28, 2022 · Terminated
  MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA,
• 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-0037-2008 · Jun 25, 2007 · Terminated
  Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implanta
• Z-0040-2008 · Jun 25, 2007 · Terminated
  Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim