BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3983999 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-14020
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA01W69, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NOT BEEN SEEN IN OVER 2 YEARS AND INDICATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) THERAPY NEVER WORKED WELL FOR THEM (HAD AN OVERALL DISSATISFACTION WITH THE THERAPY) AND WANTED THE DEVICE OUT. IMPEDANCE TESTING PERFORMED AT SHOWED VALUES >4000 OHMS ON ALL ELECTRODES. UPON EXPLANT, IT WAS FOUND THAT THE INS HAD FLIPPED OVER MULTIPLE TIMES WHICH CAUSING THE LEAD TO GET TWISTED AND KINKED WHICH LIKELY CAUSED THE HIGH IMPEDANCES AND LACK TO THERAPEUTIC EFFECT. THE DEVICES WERE REMOVED AND DISCARDED. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED THAT WERE ASSOCIATED WITH EVENT AND THE PATIENT STATUS AT THE TIME OF THE REPORT WAS NOTED AS ¿ALIVE NO INJURY¿. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459969 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention