BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4164029 · Received October 10, 2014

    Report

    Report Number
    1644487-2014-02622
    Event Type
    Death
    Date Received
    October 10, 2014
    Date of Event
    March 27, 2012
    Report Date
    September 15, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY ON (B)(6) 2012. FOLLOW-UP REVEALED THAT THE CAUSE OF DEATH WAS CHRONIC RESPIRATORY ILLNESS AND CEREBRAL PALSY. THE PATIENT WAS BURIED WITH HIS DEVICE STILL IMPLANTED; THEREFORE, NO ANALYSIS CAN BE PERFORMED. NO FURTHER INFORMATION RELEVANT TO THE PATIENT¿S DEATH HAVE BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639967 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 012991

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Death