BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEMIPULSE GEN 103

    MDR report key: 1941991 · Received December 23, 2010

    Report

    Report Number
    1644487-2010-02895
    Event Type
    Death
    Date Received
    December 23, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 23, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE PHYSICIAN THAT THE PT DIED APPROX A MONTH AGO. PER NURSE, PT HAD A SEIZURE, FELL INTO AN OPEN DRAWER AND SUFFOCATED. SHE DID NOT HAVE ANY ADD'L INFO. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAS BEEN UNSUCCESSFUL TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEMIPULSE GEN 103 LYJ CYBERONICS, INC. 103 201324

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Death