BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3086514 · Received April 30, 2013

    Report

    Report Number
    3004209178-2013-07099
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V913912, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND THE PATIENT'S PROGRAMMER DISPLAYED THE 'CALL YOUR DOCTOR' ICON AND A POR (POWER ON RESET) CONDITION. THE MANUFACTURER REPRESENTATIVE WAS ABLE TO INTERROGATE THE DEVICE WITHOUT ISSUE, IMPEDANCES WERE NORMAL AND NO CODE WAS GIVEN FOR THE POR. THE POR WAS SUCCESSFULLY CLEARED AND THE PATIENT FELT STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186391 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1