BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2873122 · Received December 13, 2012

    Report

    Report Number
    1644487-2012-03345
    Event Type
    Death
    Date Received
    December 13, 2012
    Date of Event
    May 10, 2012
    Report Date
    November 15, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT DIED FROM NEUROLOGY. FOLLOW-UP WAS MADE TO THE FUNERAL WHERE THE PATIENT WAS TAKEN AND IT WAS REPORTED THAT BASED ON THE DEATH CERTIFICATE, THE PATIENT DIED FROM RESPIRATORY FAILURE SECONDARY TO METASTATIC CANCER. THE RELATIONSHIP TO THEIR VNS IS NOT KNOWN AT THIS TIME. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS AND THUS FAR NO FURTHER INFORMATION HAS BEEN ATTAINED. THERE PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT'S TREATING NEUROLOGIST. IT WAS UNKNOWN TO THEM IF AN AUTOPSY WAS PERFORMED. THEY DID NOT KNOW IF THEIR DEATH WAS VNS RELATED OR NOT AS THEY DID NOT SEE THE PATIENT AROUND THE TIME OF DEATH. THEIR VNS WAS PROGRAMMED ON AT THE TIME THEY LAST SAW THEM SO LIKELY ON AT THE TIME OF DEATH. THEY DID NOT KNOW THE LOCATION OF DEATH OTHER THAN A HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 3038

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death