BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1022085 · Received March 28, 2008

    Report

    Report Number
    1644487-2008-00805
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PT WAS IMPLANTED WITH A NEW GENERATOR; HOWEVER, DIAGNOSTIC TESTING REVEALED THAT THE "NEW GENERATOR WAS NOT WORKING." FURTHER FOLLOW UP REVEALED THAT THE PT UNDERWENT REVISION SURGERY. DURING THE PROCEDURE, THE SURGEON COULD NOT COMMUNICATE WITH THE GENERATOR, AND HE FELT CONFIDENT THAT IT WAS NOT DUE TO THE PROGRAMMING SYSTEM. THE GENERATOR WAS REPLACED. GOOD FAITH ATTEMPTS ARE BEING DONE TO OBTAIN ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 1972

    Patients

    Seq Age Sex Outcome Treatment
    1