BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4182196 · Received October 17, 2014

    Report

    Report Number
    1644487-2014-02748
    Event Type
    Death
    Date Received
    October 17, 2014
    Date of Event
    September 7, 2009
    Report Date
    September 23, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE AVAILABLE DEATH INFORMATION HAS BEEN REVIEWED BY THE DEVICE MANUFACTURER AND WITH THE AVAILABLE INFORMATION HAS BEEN DETERMINED TO BE UNLIKELY SUDEP. THE CAUSE OF DEATH IS NEURONAL CEROID LIPOFUSCINOSIS AND CARDIAC ARREST, UNSPECIFIED.

    Description of Event or Problem · 1

    THE PHYSICIAN¿S OFFICE REPORTED THAT THE PATIENT WAS LAST SEEN ON (B)(6) 2009. THEY HAVE NO INFORMATION ON THE DEATH AND ARE UNABLE TO SPECULATE ON WHETHER THERE IS A RELATIONSHIP TO VNS. THE NATIONAL DEATH INDEX (NDI) DATABASE WAS REVIEWED INDICATING THE CAUSE AND DATE OF DEATH. THE CAUSE OF DEATH WAS REPORTED TO BE NEURONAL CEROID LIPOFUSCINOSIS AND UNSPECIFIED CARDIAC ARREST. DATE OF DEATH WAS (B)(6) 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. THE CAUSE OF DEATH AND ITS RELATIONSHIP TO VNS ARE UNKNOWN. NO FURTHER INFORMATION RELEVANT TO THE DEATH WAS PROVIDED NOR HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661855 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 7570

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Death