BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3841120 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09913
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 9, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-33, LOT# VA045AS, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIEN.T (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS NOTED THE STIMULATOR TURNED ITSELF OFF. IT WAS REPORTED, THE PATIENT WAS BEDRIDDEN AT A HOSPITAL. IT WAS NOTED, THE PATIENT HAD BEEN IN THE HOSPITAL FOR THREE MONTHS. IT WAS REPORTED, THE PATIENT HAD BED SORES AT THE STIMULATOR LOCATION. IT WAS NOTED EXPLANT WAS SUGGESTED. IT WAS REPORTED, THE PATIENT¿S DEVICE WAS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319505 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR