BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2990011 · Received March 5, 2013

    Report

    Report Number
    1644487-2013-00590
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 11, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    NO FURTHER INFORMATION HAS BEEN ATTAINED.

    Description of Event or Problem · 1

    A VNS PATIENT'S MOTHER CALLED AND REPORTED THAT ABOUT 2 WEEKS AGO, AFTER THEIR LAST CLINIC VISIT WHEN HER SETTINGS WERE ADJUSTED, SHE STATES THAT HER DAUGHTER STARTED HAVING INCREASE IN HER SEIZURE FREQUENCY THAT WAS ABOVE BASELINE. SHE SAYS THAT HER DAUGHTER ONLY HAD 1-2 SEIZURES/WEEK BEFORE THE VNS AND SHE HAD A LEAST 7 SEIZURES IN A WEEK AROUND 2 WEEKS AGO. SHE SAID THAT THEIR DOCTOR HAD INCREASED HER SETTINGS AGAIN LAST WEEK WHEN SHE WENT BACK AND THE PATIENT HAS NOT HAD ANYMORE SEIZURES SINCE THEN. IT WAS ALSO REPORTED THAT THEY HAD AN OFFICE VISIT LAST WEEK TO CHECK THE DEVICE AND THEY WERE NOT ABLE TO DETECT THE MAGNET SWIPES. SHE REPORTED THAT SHE ROUTINELY SWIPES THE PATIENT'S MAGNET EVERY DAY TO MAKE SURE IT IS WORKING. IT IS UNKNOWN IF THE DATE AND TIME WAS CORRECT ON THE HANDHELD. THIS CAN AFFECT THE DISPLAY. SHE STATES THAT HER DAUGHTER DOES NOT HAVE A RESPONSE WHEN SHE DOES THAT BUT WHEN SHE SWIPES IT DURING A SEIZURE SHE BECOMES PANICKED AND ALMOST COMBATIVE AT THAT TIME. PATIENT SETTINGS ARE NOT KNOWN AT THIS TIME. GOOD FAITH ATTEMPTS WERE MADE WITH THEIR FOLLOWING PHYSICIAN AND NO FURTHER INFORMATION HAS BEEN ATTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93843 PULSE GEN MODEL 103 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 3391

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other