BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3870360 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-11505
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF NEUROSTIMULATOR MODEL 3058 (LOT # NJY253830H ) SHOWED NO ANOMALY FOUND. FINAL ANALYSIS OF WRENCH ACCESSORY SHOWED NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# V188962, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALLER WAS CURRENTLY IN A PROCEDURE WHERE THEY WERE GOING TO JUST REPLACE THE IMPLANTABLE NEUROSTIMULATOR (INS). HOWEVER, WHEN THEY WERE GOING TO PUT THE INS ON THE LEAD, THE LEAD WAS WIPED DOWN AND SOME OF THE WIRE BECAME EXPOSED--THEY DID NOT HAVE ANOTHER LEAD TO USE SO AT THIS POINT THEY WERE UNSURE WHAT TO DO. THEY HAD OPENED THE INS ALREADY--IT WAS STILL WITHIN THE STERILE FIELD BUT THEY WERE WONDERING IF THEY CAN 'SAVE' THE INS SOMEHOW. THE DEVICE WAS BEING REPLACED DUE TO NORMAL BATTERY DEPLETION. DURING THE IMPLANT TODAY THEY DID NOT IMPLANT THE INS IN QUESTION BECAUSE THE DOCTOR DIDN'T FEEL COMFORTABLE WITH THAT. AS NOTED BEFORE, THE DOCTOR WIPED THE LEAD THAT WAS ALREADY PRESENT AND THE 'PLASTIC' PULLED BACK--THEY THEN TESTED THE LEAD AND GOT NO RESPONSE. THE HOSPITAL HAD NO STOCK OF LEADS TO USE AND SO THE OLD LEAD WAS PULLED AND NOTHING WAS IMPLANTED. INS NJY253830H IS THE DEVICE NOT PLACED BUT NOW NOT USEABLE AS IT WAS OPENED AND NOT IMPLANTED. A TENTATIVE PLAN IS TO DISCUSS ISSUE WITH PATIENT AND THEN POTENTIALLY SET UP A TIME TO IMPLANT A NEW SYSTEM. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE LEAD WAS EXPLANTED AND THE PATIENT WAS GOING TO BE RESCHEDULED FOR IMPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ISSUE TOOK PLACE DURING A SCHEDULED REPLACEMENT. IF WAS STATED THAT THE PHYSICIAN ASKED FOR THE BATTERY TO BE OPENED. WHEN THE PHYSICIAN WIPED THE PREVIOUS LEAD CLEAN, IT EXPOSED THE WIRE. THE PHYSICIAN WAS NOT COMFORTABLE USING THE NEW BATTERY BECAUSE, THE MANUFACTURER REPRESENTATIVE OR THE HOSPITAL DID NOT HAVE AN EXTRA LEAD TO USE. THE OPENED BATTERY WAS NEVER USED. THERE WAS NO PATIENT DEATH OR INJURY. THE PATIENT REPORTEDLY RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347113 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention