BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1102623 · Received August 8, 2008

    Report

    Report Number
    3004209178-2008-04802
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 11, 2008
    Manufacturer
    MPROC, JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEE MANUFACTURING #3004209178200804803. IT WAS REPORTED THAT A PATIENT HAD A LEAD FAILURE AFTER A TRIP TO A SHOPPING CENTER. THE LEAD WAS REPLACED AND THE DEVICE SYSTEM WAS FULLY FUNCTIONAL. IT WAS CONFIRMED THAT THE PATIENT IS WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 3889 LOT# B0384365K IMPLANTED| EXPLANTED