BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2991366 · Received March 6, 2013

    Report

    Report Number
    3004209178-2013-03393
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 13, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# VA02UTB, IMPLANTED: (B)(6) 2013, 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 EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE PATIENT HAD A REVISION AND HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD REPLACED. IT WAS NOTED THAT THE INS WAS REPLACED DUE TO NORMAL END OF LIFE AND THE LEAD WAS REPLACED DUE TO HIGH IMPEDANCES AND LOSS OF STIMULATION THERAPY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96217 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1