BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3190308 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10893
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    June 4, 2013
    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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS "NOT GETTING SENSATION PRIOR TO HAVING TO GO TO THE BATHROOM." STIMULATION WAS REPORTEDLY INTERMITTENT. IT WAS NOTED THAT THE PATIENT HAD DIARRHEA, FECAL AND URINARY INCONTINENCE. THE PATIENT WAS INFORMED THE DEVICE WAS PROBABLY NOT GOING TO HELP WITH DIARRHEA BUT MORE SO WITH INCONTINENCE. IT WAS INDICATED THAT THE PATIENT HAD HAD A FOLLOW-UP APPOINTMENT 3 DAYS POST-OPERATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289612 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1