BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3052915 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-06011
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 26, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3093-28, LOT# VA01GB9, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS "MALFUNCTIONING." IT WAS STATED THE DEVICE WAS NOT PROVIDING THERAPEUTIC BENEFIT. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT WITH THEIR HEALTHCARE PROVIDER AND MANUFACTURER REPRESENTATIVE WHERE THERE WILL BE AN ATTEMPT TO REPROGRAM THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157020 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1