BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4101151 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17345
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V214281, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION. IT WAS STATED THE LOCATION OF THE PATIENT¿S SYMPTOMS WAS IN THE PERINEUM. THE PATIENT WAS ADMITTED TO A SKILLED NURSING FACILITY AT THE TIME OF REPORT. THE PATIENT STATED IT WASN¿T WORKING AND IT WAS ALSO NOTED THAT THE PATIENT HAD A LOT OF DIFFICULTY BREATHING WHILE TALKING ON THE PHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584892 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1