BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2010598 · Received March 1, 2011

    Report

    Report Number
    1644487-2011-00370
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 31, 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 VNS PT HAD RECENTLY BEEN EXPERIENCING AN INCREASE IN SEIZURES WITH A FREQUENCY GREATER THAN PRE-VNS LEVELS. A BATTERY LIFE CALCULATION WAS PERFORMED THAT ESTIMATED -0.13 YEARS UNTIL GENERATOR END OF SERVICE, HOWEVER, THE ELECTIVE REPLACEMENT INDICATOR HAS NOT BEEN TRIPPED. THE PHYSICIAN IS NOT SURE WHAT HE ATTRIBUTES THE INCREASE IN SEIZURES TO, HOWEVER, HE IS ELECTING TO REPLACE THE PT'S VNS GENERATOR IN HOPES THAT IT WILL IMPROVE THE PT'S SEIZURES. NO EXTERNAL FACTORS ARE BELIEVED TO HAVE CONTRIBUTED TO THE PT'S INCREASE IN SEIZURES. IT WAS NOTED THAT THE PT'S KEPPRA DOSAGE HAD BEEN INCREASED RECENTLY. SURGERY TO REPLACE THE PT'S VNS GENERATOR HAS OCCURRED AND THE EXPLANTED GENERATOR IS CURRENTLY UNDERGOING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 285

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention