BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 5307940 · Received December 17, 2015

    Report

    Report Number
    1644487-2015-06746
    Event Type
    Death
    Date Received
    December 17, 2015
    Date of Event
    October 26, 2015
    Report Date
    November 18, 2015
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO A COMPANY REPRESENTATIVE BY THE PATIENT'S TREATING PHYSICIAN THAT A VNS PATIENT WAS DECEASED. THE TREATING PHYSICIAN DID NOT HAVE ANY ADDITIONAL DETAILS REGARDING THE PATIENT'S DEATH. ADDITIONAL RELEVANT INFORMATION HAS NOT BEEN RECEIVED TO-DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833215 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS - HOUSTON 103 4295

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death