BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1022023 · Received March 31, 2008

    Report

    Report Number
    3004209178-2008-01630
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    November 14, 2007
    Report Date
    February 26, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH THE INTERSTIM II DEVICE FELL AT WORK AND GOT AN INFECTION. THE PATIENT'S PHYSICIAN IS AWARE OF THIS AND IS NOT SURE IF THE FALL COULD HAVE CAUSED THE INFECTION. FURTHER INFORMATION 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 IMPLANTED:| IMPLANTED:| LEAD MODEL 3889 LOT# V048076| EXPLANTED:| EXPLANTED:| PROGRAMMER MODEL 3037 LOT# NJD050720N