BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1961088 · Received January 12, 2011

    Report

    Report Number
    1644487-2011-00047
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 14, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A VNS PT THAT SHE FELT FAST HEARTBEAT IN HER CHEST, TIGHTENING IN THROAT, DIFFICULTY BREATHING, AND NAUSEA WHEN COMING WITHIN 5-10 FEET OF A FAMILY MEMBER WHO HAD A PACEMAKER. PER MANUFACTURER'S LABELING, PACEMAKERS ARE NOT EXPECTED TO AFFECT THE OPERATION OF VNS SYSTEM; HOWEVER, IT IS RECOMMENDED TO KEEP A DISTANCE OF 4 INCHES OR 10 CM TO AVOID ANY INTERRUPTION. THE PT ALSO STATED THAT BY HOLDING HER MAGNET OVER THE VNS DEVICE, THE GENERATOR WAS DISABLED AND HER SYMPTOMS WERE ALLEVIATED. SHE WAS ALSO CONCERNED THAT THE DEVICE MAY BE MALFUNCTIONING DUE TO TRAUMA SHE EXPERIENCES DURING HER GRAND MAL SEIZURES; I.E. SHE FALLS DOWN DURING HER GRAND MAL SEIZURES. LASTLY, PT COMPLAINED ABOUT LACK OF EFFICACY OF DEVICE THAT VNS DEVICE HAS NEVER STOPPED A SEIZURE FOR HER. FURTHER FOLLOW UP WITH THE PT TREATING NEUROLOGIST REVEALED THAT PT HASN'T BEEN SEEN SINCE THESE ADVERSE EVENTS WERE REPORTED TO THE MANUFACTURER. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO 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 016943

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention