BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 2161857 · Received July 8, 2011

    Report

    Report Number
    1644487-2011-01539
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HAVING INCREASED SEIZURES, RELATIONSHIP TO PRE-VNS LEVELS UNK. THE PT WAS ALSO HAVING SOME METAL DETERIORATION AND TROUBLE FINDING WORDS. THE PT HAS NOT BEEN SEEN BY A PHYSICIAN IN SEVERAL YEARS, BUT HER NEW PHYSICIAN WILL REFER HER FOR GENERATOR REPLACEMENT DUE TO SUSPECTED END OF SERVICE. THE PT UNDERWENT GENERATOR REPLACEMENT 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 UNKNOWN LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention