BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 2955701 · Received February 11, 2013

    Report

    Report Number
    1644487-2013-00356
    Event Type
    Death
    Date Received
    February 11, 2013
    Date of Event
    December 8, 2012
    Report Date
    January 14, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A PHYSICIAN'S OFFICE REPORTED THAT THIS VNS PATIENT WAS DECEASED. PER THE PHYSICIAN'S OFFICE, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT 'JUST PASSED' BUT THAT THE DEATH WAS NOT RELATED TO VNS. ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN WERE UNSUCCESSFUL. ATTEMPTS FOR PRODUCT RETURN WERE UNSUCCESSFUL AS THE FUNERAL HOME DID NOT KNOW WHAT HAPPENED TO THE DEVICE. PER THE PATIENT'S DEATH CERTIFICATE, THE PATIENT'S DATE OF DEATH WAS (B)(6) 2012. THE IMMEDIATE CAUSE OF DEATH IS UNDETERMINED NATURAL CAUSES, SEIZURES, AND CONGENITAL CHROMOSOME ABNORMALITY. NO AUTOPSY WAS PERFORMED. AN IN-HOUSE SUDEP EVALUATION SHOWED THAT THE PATIENT'S DEATH WAS NOT SUDEP. PROGRAMMING HISTORY IS AVAILABLE FOR (B)(6) 2012.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE PHYSICIAN REPORTED THAT THE PATIENT'S DEATH WAS INDICATED AS SUDEP. THE PHYSICIAN INDICATED THAT THE PATIENT'S DEATH WAS NOT RELATED TO VNS. THE PHYSICIAN DID NOT PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58710 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202105

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Death