BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1023419 · Received April 2, 2008

    Report

    Report Number
    3004209178-2008-01743
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    February 1, 2008
    Report Date
    March 3, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROX THREE MONTHS POST IMPLANT THE PT WOKE UP AND WAS BLEEDING FROM THE INCISION SITE OF HER INTERSTIM DEVICE. IT WAS NOTED THAT THE PT HAD RECENTLY EXPERIENCED INFECTION AT THE POCKET SITE. THE HCP CONFIRMED THAT THE PT'S DEVICE WAS REMOVED DUE TO INFECTION AND THAT THE INFECTION WAS TREATED. FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| LEAD MODEL 3889 LOT# V038042| EXPLANTED: