InterStim™ SureScan™ 978B128 (UDI 00763000913120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000913120), received between Dec 1, 2025 and Jun 25, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Break; Difficult to Remove; Material Separation; Material Twisted/Bent; Positioning Problem; 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 THE REASON FOR CALL WAS CALLER REPORTED THE PHYSICIAN PUT THE LEAD INTRODUCER IN WITH THE SHEATH AND THE FORAMEN WAS VERY "TIGHT AND CRUNCHY" AND THE TIP OF THE PLASTIC ON THE INTRODUCER (WITH THE RADIOPAQUE IDENTIFIER) BROKE OFF. CALLER INQUIRED ABOUT MATERIAL SPECIFICATIONS AND BIOCOMPATIBILITY OF THE INTRODUCER GIVEN THAT THE TIP WAS DOWN UNDER THE SACRUM WHERE THE PHYSICIAN WAS UNABLE TO RETRIEVE IT. CALLER STATED THAT PARTIAL INTRODUCER WAS DISCARDED IN THE OR WHEN THEY HAD TO GET A NEW KIT. AGENT DOCUMENTED REPORTED INFORMATION AND REACHED OUT TO ENGINEERING FOR MORE INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619831 ↗
• MalfunctionMay 8, 2026Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION. IT WAS REPORTED THAT THE LEAD WAS DEFECTIVE AS IT'S APPEARANCE WAS NOT NORMAL. THE WIRE BETWEEN THE ELECTRODES APPEARED TO BE EXPOSED. THE CAUSE WAS UNKNOWN. THEY OPENED A NEW LEAD COMPARED THE TWO AND THERE WAS A DEFINITIVE DIFFERENCE AT THE ELECTRODE SITE. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125599 ↗
• MalfunctionMay 5, 2026Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-OBSTRUCTIVE URINARY RETENTION. IT WAS REPORTED THAT THE INTRODUCER SHEATH FROM THE LEAD KIT BROKE. THE PLASTIC PIECE AT THE TOP BROKE OFF FROM THE INNER METAL PIECE. THE CAUSE WAS UNKNOWN. A REVISION KIT WAS OPENED TO OBTAIN A NEW INTRODUCER SHEATH WHICH RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086558 ↗
• InjuryDec 1, 2025Failure to Deliver Energy; High impedance; Failure to Deliver Energy; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT'S DOCTOR PROVIDED A DETAILED SUMMARY. IN THE DETAILED SUMMARY, IT WAS NOTED THAT "PREOPERATIVE ANTIBIOTIC WITH UNACIDE 3G I.V. TIME OUT, ANESTHESIA WITH SHORT-ACTING RELAXANT, PADDED PRONE POSITION, STERILE COVERING. CAREFUL MEASUREMENT OF THE LANDMARKS AND RECORDING OF NEUROFORAMINA S3 AND S4, X-RAY FLUOROSCOPY IN THE EXACT LATERAL BEAM PATH FOR POSITION AND DEPTH CONTROL. PIERCING THE NEEDLY ELECTRODES ON BOTH SIDES OF S3, CONTINUOUS TESTING UNTIL WE GET A GOOD ANSWER. BEST RESPONSE TO NEUROFORAMEN S3 LEFT - VERY GOOD SPECIFIC RESPONSE MOTOR THRESHOLD 0.7MA. THEN PHOTO DOCUMENTATION OF THE POSITION OF THE ELECTRODES. THEN THE IMPLANTATION OF THE TINED LEAD ELECTRODES MRI-CAPABLE SYSTEM (SURESCAN), CURVED STYLET: INCISION 1CM IN THE DIRECTION OF THE POCKET, PREPARATION ALONG THE NEEDLE OF THE STYLET IS REMOVED, GUIDEWIRE TO THE MARK ON THE RESISTANCE. INSERTION OF THE TROCAR TO THE MARK ON THE VENTRAL CORTEX OF THE SACRUM. INSERT THE 28MM TINED-LEAD ELECTRODE TO THE FIRST MARK. NO MOTOR RESPONSE. THE X-RAY INSPECTION SHOWS A PERFECT POSITION. RETRACTION OF THE SLEEVE AND

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

  MAUDE report 23687287 ↗

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