BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2102330 · Received May 20, 2011

    Report

    Report Number
    3004209178-2011-03700
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    March 1, 2011
    Report Date
    May 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THE PATIENT PROGRAMMER SHOWED A POWER ON REST CONDITION AFTER THE PATIENT HAD BEEN DEFIBRILLATED. THE PATIENT HAD NOT HAD STIMULATION SINCE THE DEFIBRILLATION ON (B)(4) 2011. THE PHYSICIAN PROGRAMMER ALSO SHOWED THE POR AND THE PROCESS FOR CLEARING THE POR WAS REVIEWED WITH THE PHYSICIAN. ONCE CLEARED, THIS RESULTED IN A RETURN OF STIMULATION IN HER TYPICAL AREA FOR THE PATIENT. IMPEDANCES WERE ALL CHECKED AND WERE WITHIN 700-1000 OHMS. BATTERY LIFE SHOWED 74 MONTHS. INS APPEARED TO BE WORKING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 H0235673

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD086211N| LEAD: MODEL 3889, LOT# V234235| EXPLANTED: