InterStim™ 309201 (UDI 00763000114114)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000114114), received between Sep 17, 2020 and Mar 5, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2024Break; Difficult to Insert; Break; Difficult to Insert

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR FOR FECAL INCONTINENCE. IT WAS REPORTED THAT THE BASIC EVALUATION LEAD GOT STUCK INSIDE THE FORAMEN NEEDLE WHEN THE PHYSICIAN WAS TRYING TO REMOVE THE FORAMEN NEEDLE FROM THE PATIENT. THERE WERE NO KNOWN CONTRIBUTING F ACTORS. THE HCP TRIED REINSERTING THE LEAD WITH AND WITHOUT THE NEEDLE AND IT STILL GOT STUCK EVERY TIME. THE DEVICE WAS DISPOSED OF, THE ISSUE WAS RESOLVED. NO PATIENT SYMPTOMS WERE REPORTED.  IT WAS NOTED NO SURGICAL INTERVENTION WAS PLANNED OR HAD OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836979 ↗
• MalfunctionAug 10, 2022Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; Material Twisted/Bent

  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 THE DOCTOR REMOVED LEAD FROM PACKAGING AND NOTICED THERE WAS A KINK IN LEAD BY ELECTRODE BEFORE IMPLANTING IN PATIENT SO DID NOT USE LEAD. NO TROUBLESHOOTING WAS PE RFORMED. CAUSE WAS NOT DETERMINED. NO PATIENT/SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202340 ↗
• MalfunctionJan 13, 2022Difficult to Remove; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT USING AND EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE STYLET DID NOT COME OUT OF THE PNE LEAD SO THE DOCTOR NEEDED TO USE ANOTHER LEAD. NO SYMPTOMS/PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13250901 ↗
• MalfunctionJan 12, 2022Break; Difficult to Remove; Break; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A BASIC EVALUATION TRIAL PATIENT WHO WAS GETTING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE STYLET DID NOT COME OUT OF THE PERIPHERAL NERVE EVALUATION (PNE) LEAD, SO THE DOCTOR NEEDED TO USE ANOTHER LEAD. THERE WERE NO PATIENT SYMPTOMS NOR FURTHER COMPLICATIONS REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236502 ↗
• MalfunctionJan 12, 2022Difficult to Remove; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A BASIC EVALUATION TRIAL PATIENT WHO WAS GETTING AN EXTERNAL N EUROSTIMULATOR FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE STYLET DID NOT COME OUT OF THE PERIPHERAL NERVE EVALUATION (PNE) LEAD, SO THE DOCTOR NEEDED TO USE ANOTHER LEAD. THERE WERE NO PATIENT SYMPTOMS NOR FURTHER COMPLICATIONS REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236189 ↗
• MalfunctionSep 20, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A BASIC EVALUATION TRIAL PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE AND URGENCY FREQUENCY. IT WAS REPORTED THAT THE PHYSICIAN WENT TO IMPLANT THE LEAD AND IT WAS BROKEN. A CONTRIBUTING FACTOR MAY HAVE BEEN THE PHYSICIAN BEING A LITTLE AGGRESSIVE WITH THE LEAD SINCE THE BASIC EVALUATION LEADS ARE DELICATE. THEY OPENED ANOTHER LEAD TO USE IN THE PATIENT AND THE ISSUE WAS RESOLVED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497149 ↗
• MalfunctionJan 15, 2021Device Damaged Prior to Receipt by User; Material Twisted/Bent; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT UNDERGOING A TRIAL LEAD PLACEMENT PROCEDURE. IT WAS NOTED THAT THEY OPENED THE KIT AND PROCEEDED WITH THE PROCEDURE. WHEN APPROPRIATE PLACEMENT WAS FOUND, THE LEAD INCLUDED IN THE KIT WAS OPENED. IT WAS NOTICED THAT THE DISTAL END OF THE LEAD WAS FLACCID. THE HCP ATTEMPTED TO ADVANCE THE STYLET INTO THE LEAD FURTHER, BUT THE END OF THE LEAD WAS STILL FLACCID, EVEN WITH STYLET ADVANCED COMPLETELY. THE HCP THEN STATED THAT THEY DID NOT WISH TO USE THIS LEAD FOR THE PROCEDURE, AS THEY FELT IT WAS DEFECTIVE. ANOTHER LEAD WAS OPENED FORM THEIR BACK UP SUPPLY. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE OF THE DEFECTIVE LEAD WAS NOT DETERMINED, BUT IT WAS POSSIBLY THE STYLET NOT BEING ADVANCED FAR ENOUGH AND THE SITE LINE BEING OCCLUDED BY THE BLUE SILICONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11178350 ↗
• MalfunctionNov 6, 2020Break; Difficult to Insert; Device Damaged Prior to Receipt by User; Positioning Problem; Break; Difficult to Insert; Device Damaged Prior to Receipt by User; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL LEAD. IT WAS REPORTED THAT DURING A BASIC EVALUATION PROCEDURE, DOCTOR WAS UNABLE TO INSERT TEMPORARY LEAD BECAUSE THE LEAD WAS VISUALLY DEFECTIVE OUT OF THE PACKAGING. THE TIP OF THE LEAD WAS LOOSE FROM THE STYLET, AND THE LEAD COULDN¿T BE PLACED. DOCTOR TRIED TO MANUALLY ADVANCE THE STYLET TO THE TIP OF THE LEAD, BUT WAS UNABLE TO DO SO. NO INTERVENTION WAS NEEDED, ANOTHER LEAD WAS OPENED, AND INSERTED IT WITHOUT INCIDENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10801404 ↗
• MalfunctionNov 3, 2020Difficult to Insert; Device Damaged Prior to Receipt by User; Material Twisted/Bent; Insufficient Device Problem Information; Difficult to Insert; Device Damaged Prior to Receipt by User; Material Twisted/Bent; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A BASIC EVALUATION TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN PELVIC HEALTH INDICATIONS. IT WAS REPORTED THAT THE LEAD KINKED AND WAS UNABLE TO BE STRAIGHTENED OUT. THE KINK IN THE BOTTOM OF THE LEAD PREVENTED IT FROM BEING ABLE TO BE INSERTED INTO THE FORAMEN NEEDLE. THE PHYSICIAN TRIED TO PULL BACK ON THE LEAD TO GET THE STYLET TO STRAIGHTEN OUT AT THE BOTTOM OF THE LEAD, BUT WERE UNABLE TO REMEDY THE ISSUE INTRA-OPERATIVELY, SO A NEW LEAD WAS OPENED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE (REP). THE REP CLARIFIED THAT THERE WERE TWO LEADS THAT HAD THE SAME ISSUE (A KINK IN THE BOTTOM WHICH PREVENTED INSERTION INTO THE FORAMEN NEEDLE). THE PHYSICIAN THOUGH THESE WERE OUT OF BOX ISSUES, BUT IT WAS NOT KNOWN FOR SURE. WHEN ASKED IF THE CAUSE OF THE KINKED LEAD HAD BEEN DETERMINED, THEY REPLIED, "NO," AND WHEN ASKED WHAT MOST LIKELY CAUSE OR CONTRIBUTED TO THE ISSUE, THEY RESPONDED IT WAS UNKNOWN, BU

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10780477 ↗
• MalfunctionOct 12, 2020Break; Difficult to Insert; Peeled/Delaminated; Device Damaged Prior to Receipt by User; Break; Difficult to Insert; Peeled/Delaminated; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED FROM A FIELD CONTACT VIA A HEALTHCARE PROFESSIONAL OF A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATATOR (ENS) FOR URGENCY FREQUENCY. THE TRIAL BEGAN ON (B)(6) 2020. IT WAS REPORTED THAT THE PHYSICIAN TOOK LEAD OUT OF PACKAGE, AND DID NOT TOUCH THE LEAD EXCEPT AT BLUE END. WHEN THEY WENT TO PLACE THE LEAD IN FORAMEN NEEDLE THE LEAD STARTED TO EXTEND AND UNCOIL SO COULDN¿T USE IT. TRIED TO RETRACT THE LEAD BY PULLED BACK ON THE BLUE PART, BUT NOTHING HAPPENED. LOOKED AT THE LEAD AND THE TIP WAS EXTENDED, OPENED ANOTHER LEAD TO USE INSTEAD. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10663480 ↗
• MalfunctionSep 17, 2020Break; Difficult to Insert; Break; Difficult to Insert

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS). THE BASIC EVALUATION LEAD HAD BEEN STRETCHED A BIT UPON BEING OPENED, THEREFORE THE STYLET OF THE LEAD WAS UNABLE TO ADVANCE TO THE TIP OF THE LEAD TO KEEP IT STIFF DURING INSERTION TO THE FORAMEN NEEDLE AND IT COULD NOT BE USED. THE LEAD WAS REPLACED BY A NEW LEAD AND THE PATIENT HAD A SUCCESSFUL TEST. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10545743 ↗

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