BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2942572 · Received February 4, 2013

    Report

    Report Number
    1644487-2013-00287
    Event Type
    Death
    Date Received
    February 4, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN THE IMPLANTING HOSPITAL PROVIDED THAT PATIENT'S PRODUCT INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE VNS PATIENT HAD PASSED AWAY. IT WAS UNKNOWN WHEN SHE HAD DIED AND THE CAUSE OF HER DEATH. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN AND FOR THE PATIENT'S PRODUCT INFORMATION FROM THE IMPLANTING HOSPITAL HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46803 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 010182

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death