BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3659605 · Received March 5, 2014

    Report

    Report Number
    3004209178-2014-03935
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Report Date
    February 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3889-28, LOT# V062916, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS RECENTLY IMPLANTED AND THE DEVICE WAS NOT TURNED ON WHEN THE PATIENT LEFT THE CLINIC. IT WAS STATED THE PATIENT TRIED TO USE THE PROGRAMMER TO TURN THE DEVICE ON AND WAS GETTING A POWER ON RESET (POR) MESSAGE ON THE SCREEN. THE PATIENT WAS UPSET THEY WERE NOT GIVEN ANY INSTRUCTION ON HOW TO USE THE PROGRAMMER. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE REPORTEDLY PRE-EDUCATED THE PATIENT, BUT HAD TO GO TO ANOTHER CASE. INFORMATION RECEIVED TWO DAYS LATER INDICATED THE MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT AND REPROGRAMMED THE DEVICE. IT WAS BELIEVED THAT A BOVIE CAME CLOSE TO THE DEVICE AND CAUSED THE POR. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131632 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1