BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2153181 · Received June 23, 2011

    Report

    Report Number
    1644487-2011-01416
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 25, 2011
    Manufacturer
    CYBERONICS INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING NEW, FREQUENT OR SEVERE HEADACHES. PER CLINIC NOTES, THE PT'S SEIZURES ARE UNDER CONTROL, BUT THE VNS DEVICE IS AT END OF SERVICE. THE PT IS ALSO HAVING OBSERVED APNEAS AND IS SOMEWHAT SLEEPY DURING THE DAY. THE PT HAD GENERATOR REPLACED DUE TO END OF SERVICE ON (B)(6) 2011. ATTEMPTS FOR FURTHER INFO AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC. 102 011863

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other