BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1082619 · Received July 25, 2008

    Report

    Report Number
    3004209178-2008-04302
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    February 20, 2007
    Report Date
    June 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S DEVICE WAS EXPLANTED DUE TO INFECTION. 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 Required Intervention LEAD MODEL 3889 LOT# V008923| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION MODEL 3095 LOT# NAH034030V| IMPLANTED:| LEAD MODEL 3889 LOT# V011978| IMPLANTED: