BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1161220 · Received September 15, 2008

    Report

    Report Number
    3004209178-2008-05719
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 13, 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
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SEE ALSO MANUFACTURER REPORT 3004209178200805718. IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WITH NO STIMULATION SENSATION AND INFECTION. IT IS UNK WHAT TYPE OF INFECTION. THE PT WAS REDIRECTED TO HER PHYSICIAN. 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 LEAD MODEL 3889 LOT# V127149| IMPLANTED| EXPLANTED