BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2851687 · Received November 29, 2012

    Report

    Report Number
    1644487-2012-03151
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    August 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS SEEN BY A NEW NEUROLOGIST WHO REFERRED THE PATIENT FOR A GENERATOR REPLACED BUT DID NOT HAVE THE REASON. WHEN ASKED IT WAS SAID THAT IT MAY BE RELATED TO THE MAY HAVE BEEN DUE TO THE "LITHIUM BATTERY" OR THE SEIZURES BUT THEY HAD NO INFORMATION ABOUT THE SEIZURES OR LITHIUM POISONING ONLY THAT THEY REFERRED THE PATIENT TO A NEUROSURGEON FOR A GENERATOR REPLACEMENT GOOD FAITH ATTEMPTS WITH THE PATIENT'S FORMER NEUROLOGIST HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S MOTHER THAT HER SON HAD BEEN VERY LETHARGIC RECENTLY AND HAD BEEN EXPERIENCING AN INCREASE IN HIS SEIZURES. SHE ALSO REPORTED THAT HER SON'S WHITE BLOOD COUNT WAS LOW AND HE WAS ALSO DIAGNOSED WITH LITHIUM POISONING TWO MONTHS PRIOR. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 2258

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR