BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2597164 · Received June 4, 2012

    Report

    Report Number
    3004209178-2012-03985
    Event Type
    Malfunction
    Date Received
    June 4, 2012
    Report Date
    May 7, 2012
    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
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD, MODEL: 3889-28, LOT# V931559, IMPLANTED: (B)(6) 2012; PROGRAMMER: MODEL 3037, SERIAL# (B)(4). (B)(4).

    Description of Event or Problem · 1

    THE PATIENT FELT NO STIMULATION. THE DEVICE WAS NOT WORKING. IT WAS UNKNOWN WHAT THAT EXACTLY MEANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1