BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4182857 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19956
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 3889-28, LOT# VA0M263, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED THE DAY PRIOR TO THE REPORT AND THEY FELT LIKE THEY HAD A BLADDER INFECTION. THE PATIENT WAS ON 500 MILLIGRAMS OF CEFADROXIL ORALLY FROM THEIR IMPLANT SURGERY. FOLLOW-UP WITH THE PATIENT¿S DOCTOR INDICATED THAT THE PATIENT HAD A URINARY TRACT INFECTION. THERE WAS NO TROUBLESHOOTING DONE. A URINE SAMPLE WAS TAKEN. ACTIONS TAKEN TO RESOLVE THE ISSUE WERE LISTED AS ¿APP¿ BUT IT WAS UNCLEAR WHAT THIS MEANT. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661374 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1