BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2962278 · Received February 14, 2013

    Report

    Report Number
    1644487-2013-00407
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    December 22, 2012
    Report Date
    January 16, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT EXPIRED IN A HOSPITAL DUE TO SUDEP, BUT THEN WAS RESUSCITATED; HOWEVER, THE PATIENT REMAINS IN A "VIGIL COMA". THE VNS WAS DISABLED WITHOUT PERFORMING DIAGNOSTICS TESTING DUE TO THE PATIENT BEING A NON-RESPONDER TO VNS. THE "VIGIL COMA" IS FELT TO BE DUE TO SUDEP AND SUBSEQUENT RESUSCITATION, AND IS NOT RELATED TO THE VNS PER THE REPORTER. THE PATIENT HAD NO KNOWN SUDEP RISK FACTORS AND NO CO-MORBID CONDITIONS. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    LIMITED VNS DEVICE INFORMATION WAS PROVIDED FROM THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64340 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 3036

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R