BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1061194 · Received June 16, 2008

    Report

    Report Number
    3004209178-2008-03255
    Event Type
    Injury
    Date Received
    June 16, 2008
    Report Date
    May 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    SEE ALSO MANUFACTURER REPORT 3004209178200803266. IT WAS REPORTED THAT THE PT'S INTERSTIM DEVICE WAS REMOVED DUE TO INFECTION. THE PT WAS ON MEDICATION FOR ANOTHER CONDITION WHICH PREVENTED HER IMPLANT INCISION FROM HEALING. THE PT STILL HAS A WOUND FROM THE IMPLANT. THIS WAS THE PT'S SECOND IMPLANT REMOVED FOR 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# V015285| EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL 3037 LOT# NJD036927N| IMPLANTED:| EXPLANTED: