BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3455773 · Received November 7, 2013

    Report

    Report Number
    3004209178-2013-20379
    Event Type
    Malfunction
    Date Received
    November 7, 2013
    Report Date
    October 16, 2013
    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

    PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3889-28, LOT# V094764, IMPLANTED: 2008 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3889-28, LOT# V052586, IMPLANTED: 2007 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REPLACEMENT OF BATTERY, IT WAS NOTED THAT THE SCREW WAS LOOSE IN THE OLD BATTERY. BUT IMPEDANCES WERE ALL WITHIN NORMAL RANGE. NORMAL BATTERY DEPLETION WAS NOTED. THERE WAS NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577389 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Female