BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2915170 · Received January 15, 2013

    Report

    Report Number
    1644487-2013-00143
    Event Type
    Death
    Date Received
    January 15, 2013
    Report Date
    December 18, 2012
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, A PHYSICIAN REPORTED A VNS PATIENT DEATH. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION REGARDING THE PATIENT, PRODUCTS, AND CIRCUMSTANCES OF DEATH HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23212 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death