BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 2260289 · Received September 1, 2011

    Report

    Report Number
    1644487-2011-02050
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PROGRAMMING WAND WAS RETURNED TO THE MANUFACTURER AS THE PHYSICIAN FELT IT WAS NOT WORKING. ANALYSIS OF THE WAND REVEALED NO ANOMALIES WITH IT. ATTEMPTS FOR FURTHER INFORMATION REGARDING PATIENT AND EVENT HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN COULD NOT INTERROGATE THE PT'S GENERATOR. THE PHYSICIAN FELT THIS ISSUE WAS WITH THE PROGRAMMING WAND, BUT THIS CANNOT BE CONFIRMED AS THE PT'S GENERATOR WAS NEVER SUCCESSFULLY INTERROGATED AT APPOINTMENT. NO ADVERSE EVENTS WERE REPORTED. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1