BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2874386 · Received December 14, 2012

    Report

    Report Number
    1644487-2012-03358
    Event Type
    Death
    Date Received
    December 14, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 16, 2012
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS STATUS EPILEPTICUS. THE DATE OF DEATH WAS (B)(6) 2012. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    REVIEW OF PROGRAMMING HISTORY SHOWS SYSTEM DIAGNOSTIC RESULTS WITHIN NORMAL LIMITS ON (B)(6) 2012. ATTEMPTS FOR ADDITIONAL INFORMATION AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    CAUSE OF DEATH INFORMATION OBTAINED FROM THE NATIONAL DEATH INDEX (NDI) WAS REVIEWED BY THE MANUFACTURER WHICH INDICATED THAT THE PATIENT PASSED AWAY ON (B)(6) 2012 AND THE PATIENT'S CAUSE OF DEATH WAS ACUTE NON TRAUMATIC SUBDURAL HEMORRHAGE, EPILEPSY, AND STATUS EPILEPTICUS. A SUDEP (SUDDEN UNEXPECTED DEATH IN EPILEPSY) EVALUATION WAS PERFORMED WHICH DETERMINED THAT THE DEATH MET CRITERIA FOR CLASSIFICATION OF UNLIKELY SUDEP. THERE IS NO ALLEGATION OR OTHER INFORMATION INDICATING THAT THE DEATH IS RELATED TO VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200943

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death