BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3915413 · Received July 7, 2014

    Report

    Report Number
    3004209178-2014-12568
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3889-28, LOT# VA0FSSX, IMPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE MICROWAVE WAS REPORTEDLY INTERFERING WITH THE PATIENT¿S DEVICE. WHILE THE MICROWAVE WAS BEING USED, THE ¿SIGNAL¿ WOULD DROP DOWN AND THE PATIENT WOULD NEED TO GO TO THE BATHROOM AND REPROGRAM THE DEVICE. IT WAS ALSO STATED THE MICROWAVE WAS CHANGING THE SETTINGS ON THE PROGRAMMER FOR THE PAST THREE DAYS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE REPRESENTATIVE REACHED OUT TO THE PATIENT SHORTLY AFTER THE INITIAL REPORT OF CONCERNS WHEN USING A MICROWAVE OVEN. IT WAS STATED THERE WAS NO ISSUE WITH THE THERAPEUTIC BENEFIT AT THAT TIME. NO REPROGRAMMING WAS PERFORMED AND IT WAS BELIEVED THE PATIENT HAD BEEN RECEIVING EFFECTIVE THERAPY SINCE. A SECOND FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394859 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1