BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4521001 · Received February 17, 2015

    Report

    Report Number
    3004209178-2015-03113
    Event Type
    Injury
    Date Received
    February 17, 2015
    Report Date
    January 26, 2015
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3093-28, LOT# V863548, IMPLANTED: 2012-(B)(6), 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 A LEAD REVISION ON 2015-(B)(6) AND HAD NO BATTERY REPLACEMENT. IT WAS LATER REPORTED THAT THE PATIENT WAS DOING FINE. THE CAUSE FOR THE LEAD REVISION WAS THAT THE PATIENT FELL AND CAUSED DAMAGE TO THE LEAD. THIS WAS NOT DEVICE RELATED AS THEY WERE DOING VERY WELL WITH THE THERAPY PRIOR TO THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115061 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention