BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1191490 · Received September 26, 2008

    Report

    Report Number
    1644487-2008-02353
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    July 17, 2008
    Report Date
    August 28, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER THAT THE VNS PATIENT'S MODEL 103 GENERATOR WAS RESET TO 0MA UPON INTERROGATION. THE PATIENT WAS PREVIOUSLY SEEN IN (B) (6) 2008 WHERE THE OUTPUT CURRENT WAS SET TO 0.75MA. UPON INTERROGATION AT THE (B) (6) 2008 APPOINTMENT, THE GENERATOR WAS FOUND TO BE SET TO 0MA. ATTEMPTS TO OBTAIN THE PROGRAMMING DATA FROM THE PHYSICIANS HAND HELD FOR FURTHER ANALYSIS HAVE BEEN MADE, BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200590

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR