BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1030362 · Received April 16, 2008

    Report

    Report Number
    1644487-2008-00934
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 17, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT COMMUNICATION COULD NOT BE ESTABLISHED WITH A VNS PT'S GENERATOR. COMMUNICATION WAS ATTEMPTED WITH MULTIPLE PROGRAMMING SYSTEMS. A BATTERY LIFE ESTIMATION WAS PERFORMED, AND IT RESULTED IN 4.65 YEARS REMAINING UNTIL ERI=YES, ALTHOUGH THE VALUES USED MAY NOT BE REPRESENTATIVE OF THE PT'S EXACT PROGRAMMED PARAMETERS. THE PT UNDERWENT REVISION SURGERY. THE SURGEON NOTED THAT DURING THE REVISION THERE WAS SIGNIFICANT CORROSION AT THE GENERATOR HEADER/LEAD CONNECTOR PIN INTERFACE. THIS LED THE SURGEON TO REPLACE THE GENERATOR AND LEAD. THE EXPLANTED DEVICES HAVE BEEN RECEIVED AND ARE AWAITING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102

    Patients

    Seq Age Sex Outcome Treatment
    1