BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1101866 · Received August 7, 2008

    Report

    Report Number
    3004209178-2008-04791
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 10, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PT HAD A LOSS OF THERAPEUTIC EFFECT. HE WAS URINATING MORE FREQUENTLY AND HAVING BACK PAIN. HE WAS AT HOME. IT WAS LATER REPORTED THAT THE PT HAD HIS DEVICE REPROGRAMMED. IT WAS UNSUCCESSFUL, SO HE HAD HIS LEAD REPLACED. HE ALSO FELL ON HIS IPG. STIMULATION FELT DIFFERENT AFTER THE FALL. HE THOUGHT HE MAY HAVE DAMAGED THE IPG. THE IPG WAS REPLACED. THE PT HAS RECOVERED WITHOUT SEQUELA.

    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 EXPLANTED| LEAD MODEL 3093| EXPLANTED| EXTENSION MODEL 3095