InterStim™ SureScan™ 978B128 (UDI 00763000596910)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00763000596910), received between Apr 11, 2024 and Jan 19, 2026 — classified as 8 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2026Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION (INCONTINENCE, URGENCY, AND/OR FREQUENCY). IT WAS REPORTED THAT THE END OF THE LEAD CONTAINED A BENT TIP STYLET THAT WAS NOT CURVED AS IT TYPICALLY IS. THE PHYSICIAN WAS UNABLE TO GET THE LEAD TO CURVE PROPERLY ONCE IT WAS PLACED THROUGH THE LEAD INTRODUCER. TROUBLESHOOTING WAS PERFORMED, AND AFTER SEVERAL ATTEMPTS, THE LEAD WAS COMPLETELY REMOVED FROM THE INTRODUCER, AT WHICH POINT THE PHYSICIAN NOTICED THAT THE LEAD WAS NOT CURVED AS IT TYPICALLY IS. A NEW LEAD KIT WAS OPENED AND USED, WHICH WAS FROM THE SAME LOT NUMBER AND WAS VISIBLY CURVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24112211 ↗
• InjuryOct 15, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT DURING PROCEDURE, THE ELECTRODE SHOWED WEAKNESS IN THE REPOSITIONING BETWEEN S2 AND S3, CAUSING A FRACTURE IN THE ELECTRODE. NO CAUSE KNOWN. A NEW ELECTRODE HAD TO BE OPENED SINCE THERE WAS NO ENERGY PRESENT, AND THE PROCEDURE OCCURRED WITHOUT COMPLICATIONS AND WITH THE EXPECTED EFFICACY. ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302077 ↗
• InjuryAug 22, 2025High impedance; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; High impedance; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCE. IMPEDANCE WAS OFF IN ALL 4 ELECTRODES, >4000 OHMS. PER PROVIDER OFFICE, XRAY WAS DONE ON (B)(6) 2025 AND WAS COMPARED TO (B)(6) 2025 IMPLANT, THEY OFFER THAT THE LEAD HAS MOVED AS 2 ELECTRODES ARE NOW IN THE SACRUM. THE STATED CAUSE WAS DUE TO A PATIENT FALL. PATIENT SAID THEY HAD A HORRIBLE FALL. THEY FELL ONTO THE RIGHT ARTIFICIAL KNEE. ISSUE WAS NOT RESOLVED AND IS ONGOING. PATIENT TO BE SCHEDULED BEFORE THE END ON THE YEAR FOR A LEAD REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874662 ↗
• MalfunctionJul 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THEY HAD A LACK OF ELECTRODE CONNECTIVITY. THE INITIALLY IMPLANTED ELECTRODE DID NOT OFFER CONNECTIVITY AND THEREFORE DID NOT CONNECT WITH THE TEST CONTROL DURING THE PROCEDURE. NO KNOWN CAUSE. THE ELECTRODE REPLACEMENT WHILE STILL IN THE ROOM. ISSUE RESOLVED. IT WAS IDENTIFIED THAT THERE WAS NO CONNECTIVITY WITH THE ELECTRODE AND WITH THAT A NEW ELECTRODE WAS USED THAT THEN IT WAS POSSIBLE TO COMPLETE THE PROCEDURE. THE SURGERY OCCURRED NORMALLY AFTER THE USE OF ANOTHER ELECTRODE AND EVERYTHING WENT CORRECTLY, WITHOUT HARM TO THE PATIENT. THE ELECTRODE WILL NOT BE RETURNED OR REMOVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22682654 ↗
• MalfunctionJun 27, 2025Break; Positioning Problem; Break; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE LEAD KEPT BENDING UPWARD WHEN IT WAS PLACED. THE DOCTOR TRIED TWISTING THE LEAD TO CHANGE THE ANGLE BECAUSE THEY SAID IT FELT LIKE THE LEAD WAS HITTING SOMETHING. WHEN THEY REMOVED THE LEAD TO REPOSITION ELECTRODE 0 SNAPPED OFF. THEY USED A NEW LEAD AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345121 ↗
• MalfunctionJun 11, 2025Component Missing; Component Missing

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PLASTIC STRAW WASN'T PRESENT IN THE KIT. THE CUSTOMER COULDN'T TUNNEL AND THEY HAD TO OPEN ANOTHER KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181775 ↗
• MalfunctionApr 3, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THIS WAS AN OUT OF BOX ISSUE. THE CAUSE OF THE LEAD BEING FRAYED AND THE RUBBER COMING OFF EXPOSING THE WIRES WAS UNKNOWN. NO STEPS WERE TAKEN TO RESOLVE THIS ISSUE BUT IT WAS REPORTED THAT THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761592 ↗
• MalfunctionMar 19, 2025Component Missing; Component Missing

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE SURESCAN LEAD KIT WAS MISSING THE STRAW. MANUFACTURER REPRESENTATIVE (REP) STATED THAT THE STRAW WAS NOT LOADED AND WAS MISSING OFF THE TUNNELING TOOL. NO CAUSE KNOWN. A REVISION KIT WAS OPENED TO BE ABLE TO USE THE STRAW FOR TUNNELING THE LEAD. NO ISSUE WITH PATIENT. THE REVISION KIT CONTAINED A REPLACEMENT ITEM TO RECTIFY THE SITUATION OF THE MISSING STRAW IN THE LEAD KIT. RESOLVED CASE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641629 ↗
• MalfunctionMar 17, 2025Overheating of Device; Material Deformation; Overheating of Device; Material Deformation

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION AND URGE INCONTINENCE IT WAS REPORTED THAT THEY STARTED URINATING A LOT MORE ABOUT 4 DAYS AGO. PATIENT MENTIONED THAT THEY CALLED ABOUT A MONTH AGO AND WAS TRYING TO INCREASE THEIR SETTINGS AND WAS HAVING SOME ISSUES. PATIENT STATED THAT PROGRAMS 1-7 ARE NO LONGER WORKING AND THE REPRESENTATIVE SET THEM UP WITH ANOTHER SET OF GROUPS A, B, C, AND D. PATIENT SAID THAT A AND B HAD STOPPED WORKING AND THEY WERE NOT ABLE TO INCREASE STIMULATION PAST 0.1MA. PATIENT ALSO MENTIONED THAT CHANNEL D WAS WORKING FOR NOW. CALLER STATED THAT THEY WERE GIVEN THE CUSTOMIZE PROGRAMS ON 2/24 AND THEY WORKED FOR ABOUT SIX DAYS BEFORE THEY STARTED TO HAVE A RETURN OF SYMPTOMS. PATIENT ASKED IF THE REPRESENTATIVE CAN GO BACK IN AND REPROGRAM THE 4 CUSTOMIZED PROGRAMS THAT THE REPRESENTATIVE GAVE HIM. AGENT REVIEWED INFORMATION WITH THE PATIENT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. CALLER ALSO MENTIONED THAT THEY ALSO WERE GETTING A BURNING SENSATION WHAT THEY FEEL LIKE AT THE LEAD-ELECTRODE SIGHT. CALLER STATED THAT WHEN THEY

  Patient problems: Burning Sensation; Pain

  MAUDE report 21619432 ↗
• InjuryMar 12, 2025Unintended Collision; Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Unintended Collision; Energy Output 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) FOR URINARY DYSFUNCTION. IT WAS REPORTED THAT THE PATIENT HAD A FOLLOW-UP APPT IN THE HEALTHCARE PROVIDER'S (HCP) OFFICE TODAY AFTER HAVING A COUPLE FALLS ROUGHLY 2 WEEKS AGO. PATIENT HAD PAIN AT LEAD AND IPG SITE AND MINIMAL TO NO SYMPTOM IMPROVEMENT AFTER THE FALL. WENT IN FOR WELL CHECK TODAY WITH THE HCP AND HAD A PROGRAM ADJUSTMENT FROM PROGRAM 3 TO PROGRAM 6, STIM UNCOMFORTABLE STILL AND MAY TURN THERAPY OFF IF DISCOMFORT PERSISTS. THERE WERE NO OUT-OF-RANGE IMPEDANCES AND PATIENT WAS SENT FOR SACRAL X-RAYS. THE PATIENT PLANNED ON GETTING X-RAYS TODAY OR TOMORROW WITH A FOLLOW-UP WITH THE HCP'S OFFICE AFTER RESULTS CAME IN. THE MANUFACTURER REPRESENTATIVE WAS UNSURE OF FURTHER TREATMENT AS OF NOW. THEY STATED THAT THE PATIENT HAD PAIN, DISCOMFORT/SORENESS/PINCHING/ACHE/PRESSURE, RETURN OF BASELINE SYMPTOMS, URINARY INCONTINENCE, URINARY FREQUENCY, URINARY URGENCY. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE. IT WAS REPORTED THAT THE SYMPTOMS DID WORSEN AFTER THE FALL WITH NO IMPROVEMENT WITH PROGRAM ADJUSTMENTS

  Patient problems: Discomfort; Insufficient Information; Micturition Urgency; Pain; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 21588491 ↗
• MalfunctionFeb 4, 2025Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION AND URGE INCONTINENCE. IT WAS REPORTED THAT SHORTLY AFTER THEY HAD AN MRI ABOUT A MONTH AGO, THEY FELT LIKE THE THERAPY WASN'T WORKING QUITE RIGHT. CALLER STATED THAT THEY CAN NEVER TELL IF THEIR BLADDER IS EMPTY OR NOT AND IN THE MORNINGS IT SEEMS LIKE IT'S A VERY SLOW FLOW. CALLER ADDED THAT THEY ALSO HAVE A PROLAPSE AND DON'T KNOW IF THAT'S CAUSING IT. CALLER MENTIONED THAT THEY HAD TO TURN THE THERAPY OFF FOR THE MRI AND THOUGHT THEY HAD TURNED IT BACK ON, BUT THEY WEREN'T SURE IF IT WAS WORKING OR NOT. CALLER SAID THEY CHARGED THE HANDSET THE OTHER DAY BUT COULDN'T CHARGE THE RECHARGER BECAUSE THEY LOST THEIR CHARGING CORD. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE CHARGING CORD AND AC POWER ADAPTER. AGENT REVIEWED WITH CALLER TO CALL BACK IF THEY NEED FURTHER ASSISTANCE WITH TROUBLESHOOTING.

  Patient problems: Dysuria; Insufficient Information

  MAUDE report 21305259 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED ELECTRODE DAMAGE.  DURING THE IMPLANTATION OF THE ELECTRODE WE WERE ABLE TO VERIFY THAT IT WAS NOT CORRECTLY ASSEMBLED IN THE AREA OF THE POLES THAT ARE INTRODUCED INTO THE EXTENSION. NO CAUSE KNOWN.  DAMAGED ELECTRODE WAS DISCARDED.  THEY HAD TO REMOVE THE ELECTRODE AND PLACE A NEW ONE WITH THE SAME BATCH NUMBER.  ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293921 ↗
• InjuryJan 21, 2025Adverse 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 THE PATIENT QUIT BREATHING AS WE WERE ATTEMPTING TO PLACE FOREMAN NEEDLE. PATIENT HAD TO BE FLIPPED OVER TO GET A GOOD AIRWAY. PATIENT SEEN IN ER POST PROCEDURE FOR ADDITIONAL WORK UP BUT WAS BACK TO NORMAL BASELINE IN RECOVERY PRIOR TO ER VISIT. THE ISSUE WAS RESOLVED.

  Patient problems: Apnea

  MAUDE report 21196888 ↗
• InjuryJan 7, 2025Adverse 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) FOR URINARY DYSFUNCTION. IT WAS REPORTED THAT THE PATIENT STOPPED BREATHING DURING THE PROCEDURE AND HAD TO BE FLIPPED OVER MID-PROCEDURE. THE MANUFACTURER REPRESENTATIVE (REP) LEFT THE ROOM AND RETURNED AFTER THE PATIENT WAS INTUBATED. THE SURGERY RESUMED. THE ONLY THING LEFT TO FINISH WAS CLOSING THE INCISIONS.

  Patient problems: Apnea; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092213 ↗
• InjuryJan 2, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE INS SITE.  SHARP JOLT LIKE PAIN AT TIMES WHEN THEY  MOVES FEELS JOLT DOWN LEFT SCIATIC AREA. WILL PLAN FOR GENERATOR REVISION IN OR. WILL PLAN TO OBTAIN PELVIC XRAYS TO INVESTIGATE EVIDENCE OF LEAD MIGRATION. IT WAS LATER  REPORTED THAT THE LEAD   MIGRATION/DISLODGEMENT      REPROGRAMMED SPECIFY ACTION: LEFT ON PROGRAM 1 AT 1.2 PW 180. CUSTOM PROGRAMS CREATED.  MAGING (X-RAY, MRI, CT SCAN, ETC) SPECIFY RESULTS: PELVIC XRAY SHOWED SOME MIGRATION OF THE LEAD DATE OF TEST: (B)(6)2024 / DIAGNOSTIC TYPE: PATIENT REPORTED SPECIFY RESULTS: PAIN AT IPG SITE DATE OF TEST: (B)(6)2024 / DIAGNOSTIC TYPE: EXAMINATION SPECIFY RESULTS: PHYSICAL EXAMINATION BY PROVIDER TO ASSESS WHERE PAIN WAS COMING FROM. DATE OF TEST: (B)(6) 2024  EXPLANTED/REPLACED COMPONENT: ENTIRE SYSTEM ACTION DATE: 12-NOV-2024. THE EVEN IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21064022 ↗
• MalfunctionDec 10, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION (INCONTINENCE, URGENCY, AND/OR FREQUENCY). IT WAS REPORTED THAT THE LEAD WAS DAMAGED. THE INNER WIRE DEPARTED FROM THE SHEATH DURING SURGERY. CAUSE WAS NOT DETERMINED. NO TROUBLESHOOTING WAS PER FORMED. THE ISSUE WAS CONFIRMED RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894592 ↗
• MalfunctionDec 6, 2024Positioning Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) WAS UNABLE TO ADVANCE LEAD DUE TO RESISTANCE MET. TRIED TO REPOSITION LEAD. CHECKED PLACEMENT IN SEVERAL VIEWS. RE-ATTEMPTED TO PLACE LEAD AND REPOSITION. THE CAUSE OF THE ISSUE WAS UNKNOWN. IT WAS REPORTED THAT THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864983 ↗
• MalfunctionNov 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PUNCTURE SHEATH WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20686110 ↗
• MalfunctionNov 13, 2024Unsealed Device Packaging; Unsealed Device Packaging

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT BROKEN PLASTIC ELECTRODE PACKAGING. THE ELECTRODE KIT STERILITY COMPROMISED BY BROKEN PLASTIC BOX. NO CAUSE KNOWN. NO DIAGNOSTICS/TROUBLESHOOTING PERFORMED. THE PAT IENT WAS NOT IMPLANTED AND THE ELECTRODE WAS RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675282 ↗
• MalfunctionNov 8, 2024High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT DURING PROCEDURE, MEASUREMENT OF IMPEDANCES 3 CONTACTS HAD HIGH IMPEDANCES, OVER 4000 OHMS. CAUSE UNKNOWN. THEY REPLACED THE LEAD WITH ANOTHER LEAD AND THE ISSUE WAS SOLVED. ALL CONTACTS HAD IMPEDANCES IN A GOOD LEVEL. WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20644996 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR. IT WAS REPORTED THAT THE DEVICE WAS REMOVED AS THE IMPLANT WAS CAUSING SCIATIC NERVE PAIN.

  Patient problems: Pain

  MAUDE report 20623574 ↗
• MalfunctionOct 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT DURING LEAD PLACEMENT SURGERY THE DOCTOR NOTICED THE BLUE RAISED LEAD GUIDE ON THE LEAD THAT INDICATES THE DIRECTION OF THE BEND AT THE DISTAL END OF THE LEAD DID NOT ACCURATELY SHOW THE BEND. ON INVESTIGATION THE BLUE PORTION OF THE LEAD TURNED FREELY AND CAME OUT VERY EASILY. LEAD REPLACED. IMPLANT COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20519136 ↗
• MalfunctionOct 10, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED. THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THE LEAD WAS REPLACED WITH ANOTHER LEAD, AND THE OLD LEAD WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20421189 ↗
• MalfunctionOct 7, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING AN ISSUE THAT WAS NOTICED DURING PATIENT'S STAGE 1 OPERATION. IT WAS REPORTED THAT THERE WAS AN ELECTRODE DAMAGE. THE DISTAL TIP WAS BROKEN BETWEEN MOST DISTAL ELECTRODE (CALLED AS ¿0¿) AND ONE ABOVE IT (CALLED AS ¿1¿). IT WAS A NORMAL ¿STAGE1¿ PROCEDURE AND NOTHING UNUSUAL. CUSTOMER OPENED PACKET AND PAID ATTENTION THAT ELECTRODE WAS DAMAGED. CUSTOMER TOOK NEW PACKET AND IMPLANTED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384972 ↗
• MalfunctionSep 30, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT AN INTRAOPERATIVE LEAD ISSUE/SURGICAL COMPLICATIONS. DAMAGED LEAD. NO CAUSE KNOWN. LEAD REVISED, SHIFTED DILATOR. NO RETURNED AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339964 ↗

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-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
• 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