BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1102423 · Received August 7, 2008

    Report

    Report Number
    3004209178-2008-04762
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    April 14, 2008
    Report Date
    July 9, 2008
    Manufacturer
    MPROC, JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT NEVER HAD THERAPEUTIC EFFECT FROM HER DEVICE. THE DEVICE WAS REPROGRAMMED WITHOUT SUCCESS. THE PT UNDERWENT SURGERY TO REPLACE THE LEAD. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MPROC, JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL 3037