BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3050788 · Received April 10, 2013

    Report

    Report Number
    1644487-2013-00979
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    April 1, 2009
    Report Date
    March 12, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PROGRAMMING HISTORY FORM WHICH INCLUDED THE PATIENT'S AVERAGE SEIZURE FREQUENCY PER MONTH WAS RECEIVED FROM THE TREATING REGISTERED NURSE. ON (B)(6) 2009, THE PATIENT'S AVERAGE NUMBER OF SEIZURE PER MONTH WAS LISTED AS 12 AND 20, RESPECTIVELY. LATER ON (B)(6) 2010, THE AVERAGE SEIZURE FREQUENCY PER MONTH WAS LISTED AS 2-5. IT WAS PREVIOUSLY DOCUMENTED THAT THE PATIENT'S SEIZURE FREQUENCY PER MONTH PRIOR TO IMPLANT WAS 5-10. THE PATIENT HAD GENERATOR REPLACEMENT SURGERY ON (B)(6) 2009. SINCE THE INCREASED SEIZURES OCCURRED AFTER GENERATOR REPLACEMENT (AT APPROXIMATELY TWO MONTHS), IT IS REASONABLY ASSUMED THE GENERATOR WAS NOT NEARING END OF SERVICE. FROM THE NURSE'S PROVIDED PROGRAMMING HISTORY, IT APPEARS THAT THE DEVICE WAS STILL BEING TITRATED TO SETTINGS REACHED PRIOR TO GENERATOR REPLACEMENT IN (B)(6) 2009. NORMAL MODE AND LEAD DEVICE DIAGNOSTICS ON (B)(6) 2010 WERE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149799 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 200994

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR