BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3232732 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11931
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 26, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER; PATIENT PRODUCT ID 3 889-28, LOT# V686988, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED DISCOMFORT AND PAIN AT THE IMPLANT SITE FOR SEVERAL MONTHS. THE DEVICE SEEMED LIKE IT HAD MOVED IN THE POCKET. THE DEVICE WAS REPORTEDLY NOT SITTING SQUARE LIKE IT WAS INITIALLY AT IMPLANT; IT APPEARED TO BE SITTING AT AN ANGLE. IT WAS NOTED THAT IF THE PATIENT SAT A CERTAIN WAY IT WAS VERY UNCOMFORTABLE AND PAINFUL. THE PATIENT WANTED THE THERAPY REMOVED. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333366 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR