BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4925881 · Received July 20, 2015

    Report

    Report Number
    1644487-2015-05263
    Event Type
    Death
    Date Received
    July 20, 2015
    Date of Event
    June 14, 2013
    Report Date
    June 25, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INADVERTENTLY REPORTED THE DEATH WHEN THERE WAS NO BELIEVED RELATIONSHIP TO VNS. THIS EVENT SHOULD NOT HAVE BEEN REPORTED. EVALUATION CODES, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY REPORTED THE DEATH WHEN THERE WAS NO BELIEVED RELATIONSHIP TO VNS. NO DEVICE FAILURE IS SUSPECTED. THIS EVENT SHOULD NOT HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    BASED ON THE CAUSES OF DEATH, THERE IS NO SUSPECTED RELATIONSHIP BETWEEN THE DEATH AND VNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS STUDY PATIENT PASSED AWAY ON (B)(6) 2013. THE NATIONAL DEATH INDEX FROM THE CDC WEBSITE LISTED THE PATIENT'S CAUSE OF DEATH AS UNSPECIFIED CIRRHOSIS OF LIVER, PNEUMONIA, ACUTE RESPIRATORY FAILURE, AND CHRONIC KIDNEY DISEASE (STAGE 5). THE RELATIONSHIP OF THE DEATH TO VNS IS UNKNOWN. NO FURTHER INFORMATION RELEVANT TO THE PATIENT'S DEATH HAS BEEN RECEIVED TO DATE. BASED ON THE AVAILABLE INFORMATION ABOUT THE PATIENT¿S DEATH, AN INTERNAL CLASSIFICATION HAS DETERMINED THAT THE DEATH WAS UNLIKELY SUDEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468892 PULSE GEN MODEL 102 GENERATOR MUZ CYBERONICS, INC. 102 015709

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death