BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3802744 · Received May 9, 2014

    Report

    Report Number
    1644487-2014-01236
    Event Type
    Death
    Date Received
    May 9, 2014
    Date of Event
    April 13, 2014
    Report Date
    April 14, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN TO THE PHYSICIAN'S OFFICE. THE ONLINE OBITUARY WAS FOUND WHICH NOTED THAT THE PATIENT DIED ON (B)(6) 2014 IN THE HOSPITAL. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE RELATIONSHIP BETWEEN VNS AND THE CAUSE OF DEATH ARE UNKNOWN.

    Description of Event or Problem · 1

    THE VNS PATIENT¿S DEVICE WAS NOT EXPLANTED AFTER HE PASSED AWAY; THEREFORE, NO ANALYSIS CAN BE PERFORMED. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280689 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202518

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Death