BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1011299 · Received March 10, 2008

    Report

    Report Number
    1644487-2008-00660
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 12, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT "THEY COULD NOT COMMUNICATE WITH THE PT'S DEVICE." REPORTED "PHYSICIAN IS VERY GOOD WITH VNS". HE STATED "HE DID ALL THE TROUBLESHOOTING, AND EVEN USED ANOTHER PHYSICIAN'S HANDHELD COMPUTER AND COULD NOT GET ANY COMMUNICATION. HE DOES NOT FEEL THE PT'S VNS GENERATOR SHOULD BE AT END OF BATTERY LIFE." ADDITIONALLY, IT WAS REPORTED "THE PT HAS HAD MORE SEIZURES, BUT BELOW BASELINE." THE PT HAD "A BAD FALL" A FEW WEEKS BACK AND THE PHYSICIAN THINKS IT MIGHT HAVE DAMAGED THE DEVICE." THE PT HAD THEIR GENERATOR REPLACED AND IS PENDING ANOTHER SURGERY DATE FOR A FULL REVISION. A MALFUNCTION IS SUSPECTED AGAINST THE GENERATOR. THE EXPLANTED GENERATOR IS AT THE MFR PENDING ANALYSIS COMPLETION. GOOD FAITH ATTEMPTS HAVE BEEN MADE AT THE SITE FOR ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 9728

    Patients

    Seq Age Sex Outcome Treatment
    1