BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3822043 · Received May 20, 2014

    Report

    Report Number
    1644487-2014-01338
    Event Type
    Death
    Date Received
    May 20, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 25, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS PENDING THE COMPLETION OF AN AUTOPSY; HOWEVER, IT WAS REPORTED THAT IT IS BELIEVED THAT THE DEATH WAS SEIZURE RELATED. IT WAS REPORTED THAT THE GENERATOR AND LEAD WERE BOTH EXPLANTED; HOWEVER, THAT THE LEAD WAS DISCARDED. THE GENERATOR WOULD BE RETURNED FOR ANALYSIS. THE GENERATOR WAS RECEIVED FOR ANALYSIS ON (B)(6) 2014. ANALYSIS OF THE GENERATOR IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED GENERATOR WAS COMPLETED. MONITORING OF THE DEVICE OUTPUT SIGNAL SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300450 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 3786

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death