BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2140919 · Received June 22, 2011

    Report

    Report Number
    1644487-2011-01394
    Event Type
    Death
    Date Received
    June 22, 2011
    Date of Event
    January 3, 2011
    Report Date
    May 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PHYSICIAN THAT THE PATIENT HAD EXPIRED. THE PHYSICIAN DID NOT KNOW THE EXACT DIAGNOSIS BUT STATED THEY BELIEVED THE PATIENT TO HAVE BEEN KILLED IN A HOMICIDE. A REVIEW OF THE MANUFACTURER'S DATABASES SHOWED THE PATIENT'S DEVICE TO BE PROPERLY FUNCTIONING ON (B)(6) 2009. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    CAUSE OF DEATH INFORMATION OBTAINED FROM THE (B)(6) WAS REVIEWED BY THE MANUFACTURER WHICH INDICATED THAT THE PATIENT PASSED AWAY ON (B)(6) 2011 AND THE PATIENT'S CAUSE OF DEATH WAS "ACCIDENTAL POISONING BY AND EXPOSURE TO NARCOTICS AND PSYCHODYSLEPTICS [HALLUCINOGENS], NOT ELSEWHERE CLASSIFIED, UNSPECIFIED MENTAL AND BEHAVIORAL DISORDER DUE TO USE OF TOBACCO, MENTAL AND BEHAVIORAL DISORDERS DUE TO MULTIPLE DRUG USE AND USE OF OTHER PSYCHOACTIVE SUBSTANCES, HARMFUL USE, ESSENTIAL (PRIMARY) HYPERTENSION, ATHEROSCLEROTIC CARDIOVASCULAR DISEASE, SO DESCRIBED, OTHER FORMS OF CHRONIC ISCHEMIC HEART DISEASE, OTHER AND UNSPECIFIED CONVULSIONS, POISONING BY COCAINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 010657

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death