BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4100114 · Received September 18, 2014

    Report

    Report Number
    3004209178-2014-17338
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # VA0JBNW, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID NEU_UN KNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED YESTERDAY AND THEIR FAMILY MEMBER WAS TRYING TO TURN STIMULATION ON TODAY AND WAS GETTING THE POWER ON RESET (POR) SCREEN WITH THE ¿CALL YOUR DOCTOR¿ ICON. THE PATIENT¿S FAMILY MEMBER WAS NOT BEING ABLE TO ADJUST STIMULATION AND WOULD CONTACT THE MANUFACTURER REPRESENTATIVE. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578416 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR