BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1150252 · Received September 3, 2008

    Report

    Report Number
    3004209178-2008-05402
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE STIMULATION WAS TURNED UP ENOUGH TO AID IN BLADDER CONTROL, THE PT EXPERIENCED FECAL INCONTINENCE. THE SYSTEM WAS REPLACED. DURING THE REPLACEMENT SURGERY THE PT BEGAN TO THROW UP AND HAD DIFFICULTY BREATHING. SHE WAS TURNED OVER TO TRY TO STABILIZE HER SYMPTOMS. ONCE SHE WAS STABILIZED SHE WAS FLIPPED BACK OVER AND THE SURGERY WAS CONTINUED. THE STERILE FIELD WAS BROKEN. THE PT WAS DISCHARGED ONE DAY LATER FROM THE HOSPITAL. SHE STILL HAD SOME DIFFICULTY WITH HER BREATHING. THE THROWING UP AND DIFFICULTY BREATHING MAY HAVE OCCURRED WITH THIS PT IN PAST SURGERIES. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANTED| LEAD MODEL 3093 LOT# V093742| EXTENSION MODEL 3095 LOT# NAH037589V| EXPLANTED| IMPLANTED| EXPLANTED