BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3715018 · Received March 31, 2014

    Report

    Report Number
    1644487-2014-00839
    Event Type
    Death
    Date Received
    March 31, 2014
    Date of Event
    December 9, 2010
    Report Date
    March 5, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE VNS PATIENT¿S DEVICE WAS NOT EXPLANTED AFTER PASSING AWAY. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION WERE MADE BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY FROM STATUS EPILEPTICUS. THE PATIENT¿S OBITUARY STATED THAT THE PATIENT DIED IN THE HOSPITAL ON 12/09/2010 AND FACED LIFELONG MEDICAL CHALLENGES OF TUBEROUS SCLEROSIS. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION WERE MADE BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    A COPY THE DEATH CERTIFICATE WAS RECEIVED WHERE IT STATES THAT THE IMMEDIATE CAUSE OF DEATH WAS PROBABLE CARDIAC DYSRHYTHMIA DUE TO ANGIOMYOLIPOMAS OF THE HEART IN ASSOCIATION WITH TUBEROUS SCLEROSIS. AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191055 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 8521

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death