InterStim™ SureScan™ 978B133Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000203764), received between Feb 11, 2021 and Dec 27, 2022 — classified as 2 injuries, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THEY REPORTED THAT THE CAUSE WAS NOT DETERMINED AND THEY HAD NO IDEA WHAT MOST LIKELY CONTRIBUTED TO THE ISSUE. WHEN ASKED WHAT STEPS WERE TAKEN TO RESOLVE THE ISSUE, THEY REPORTED ON THE DATE OF THE CASE, (B)(6) 2022, THEY REMOVED THE LEAD, OPENED A NEW LEAD AND PLACED IT. THAT SEEMED TO RECTIFY THE SITUATION. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056842 ↗
• MalfunctionJul 14, 2022Break; Difficult to Insert; Break; Difficult to Insert

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION (INCONTINENCE, URGENCY, AND/OR FREQUENCY). IT WAS REPORTED THAT IT WAS A DIFFICULT LEAD PLACEMENT AND THE SURGEON NOTICED SMALL RIDGES ON THE END OF THE NEEDLES. HE ASKED FOR REPLACEMENT NEEDLES. THEREFORE, I HAD TO OPEN ANOTHER LEAD. THE LEAD WAS SUCCESSFULLY IMPLANTED BUT WE USED THE NEEDLES FROM ANOTHER LEAD KIT WITH THE SAME LOT NUMBER. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15013841 ↗
• MalfunctionOct 4, 2021Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE REP STATED EVERYTHING HAPPENED SO FAST. THE REP STATED THEY WERE IN THE OPERATION, THEY WENT TO OPEN THE LEAD AND THE INNER PACKAGE OF THE LEAD WASN¿T SEALED SO IT WASN¿T STERILE. THEY DIDN¿T USE IT AND THE REP LEFT TO GET ANOTHER ONE AND WENT THE REP WENT BACK TO THE OPERATING ROOM, THE HEALTHCARE PROVIDER (HCP) HAD THROWN IT AWAY IN THE WASTE BAG. THE LEAD WAS STICKING OUT THROUGH THE PLASTIC IN THE TOP AND WAS NOT STERILE. THE REP IS SURE THAT IT WASN¿T DROPPED OR MISHANDLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568975 ↗
• InjuryOct 1, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT DURING STAGE 1 TRIAL, THEY WERE ON HIGH AMP LEVELS AND LITTLE SYMPTOM RELIEF. IT WAS ALSO REPORTED THAT THERAPY DID NOT WORK FOR TRIAL PATIENT DURING STAGE 1. UPON REMOVAL OF TRIAL PATIENT'S LEAD, IT WAS DETERMINED THAT THE LEAD MIGRATED OUT OF THE SACRUM. THERE WAS A POSSIBILITY OF PATIENT EXERTION AND MOVEMENT THAT CONTRIBUTED TO THE MIGRATION. NO XRAYS TAKEN BUT HCP REMOVED THE LEAD COMPLETELY.

  Patient problems: Insufficient Information

  MAUDE report 12565983 ↗
• MalfunctionFeb 11, 2021Positioning Problem; Insufficient Device Problem Information; Positioning Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT UNDERGOING AN IMPLANT FOR NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL /PELVIC FLOOR THERAPY IT WAS REPORTED THAT THE DOCTOR NOTICED A RIDGE ON THE DISTAL END OF THE FORAMEN NEEDLE. THE DOCTOR SAYS THE RIDGE CAUSES THE NEEDLE TO CATCH ON THE TISSUE AND DOES NOT ALLOW FOR IT TO SMOOTHLY MOVE, HOWEVER DID NOT THINK ANY ADDITIONAL DAMAGE OCCURRED IN THE PATIENT.  IT JUST SLID THROUGH THE TISSUE SMOOTHLY LIKE IT NORMALLY DOES. WHEN ASKED TO GIVE MORE DETAIL AROUND WHAT WAS MEANT BY "RIDGE", THEY SAID IT COULD MAYBE BE DESCRIBED AS A DIVOT, OR DIP IN THE NEEDLE TOWARD THE DISTAL END. THEY CLARIFIED THE NEEDLE DAMAGE WAS NOTICED AFTER IT WAS TAKEN OUT OF THE PACKAGE. THE SURGEON REPORTED THERE WAS PHYSICALLY SOMETHING WRONG WITH THE FORAMEN NEEDLE AND ASKED THAT THEY SEND IT IN FOR EVALUATION. THE DOCTOR HAD THE REP OPEN 5¿ FORAMEN NEEDLES THAT DID NOT HAVE THE RIDGE ON THEM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11315970 ↗

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