BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3881144 · Received June 18, 2014

    Report

    Report Number
    1644487-2014-01522
    Event Type
    Death
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOW-UP WITH THE VNS PATIENT¿S NEUROLOGIST REVEALED THAT THE PATIENT WAS LAST SEEN IN HIS OFFICE ON (B)(6) 2012. NO INFORMATION WAS AVAILABLE REGARDING THE PATIENT¿S DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358700 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 2476

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death