BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2020254 · Received March 11, 2011

    Report

    Report Number
    1644487-2011-00460
    Event Type
    Death
    Date Received
    March 11, 2011
    Date of Event
    October 28, 2002
    Report Date
    February 9, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN INITIAL REPORT FROM A PHYSICIAN'S OFFICE STATED THAT A VNS PT HAD PASSED AWAY. NO CAUSE OF DEATH WAS FOUND IN THE PT'S NOTES AT THIS TIME. A SEARCH OF THE MFR'S PROGRAMMING HISTORY DATABASE SHOWED THAT ON (B)(6) 2002, THE PT WAS SET TO 1.75 MA/30 HZ/500 MICROSEC/5 MIN. THIS IS APPROX SIX MONTHS BEFORE THE PT EXPIRED, AND DIAGNOSTICS ON THIS DAY SHOWED PROPER DEVICE FUNCTION WITH DCDC=2 AND EOS=NO. GOOD FAITH ATTEMPTS TO GAIN MORE INFO SURROUNDING THE EVENTS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 4136

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death