BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2191594 · Received July 20, 2011

    Report

    Report Number
    1644487-2011-01638
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A VNS PROGRAMMING SITE IN THE (B)(6) REPORTED THAT THEY HAD A VNS PT WHO WAS HAVING AN INCREASE IN SEIZURES. IT IS NOT KNOWN AT THIS TIME IF THEIR SEIZURES ARE ABOVE OR BELOW THEIR PRE-VNS BASELINE RATE. THE PT WAS IMPLANTED IN 2003; HOWEVER, ON INTERROGATION, IS NOT NEAR END OF SERVICE. DCDC 2 WITH COMMUNICATION AND OUTPUT STATUS OK, OPERATING TIME OF 20,340 HRS AND A TOTAL ON TIME OF 11,124 HRS. THE PT WILL NOT BE SEEN AGAIN TILL (B)(6) 2011. THEIR DUTY CYCLE WAS ADJUSTED AT THEIR OFFICE VISIT. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS ABOUT THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 4136

    Patients

    Seq Age Sex Outcome Treatment
    1