BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1132594 · Received August 22, 2008

    Report

    Report Number
    3004209178-2008-05154
    Event Type
    Injury
    Date Received
    August 22, 2008
    Report Date
    July 24, 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 THAT THE PT HAD HER IPG AND LEAD EXPLANTED DUE TO AN INFECTION. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    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 LEAD MODEL 3093 LOT# V071771 IMPLANTED| EXPLANTED