BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2093256 · Received May 3, 2011

    Report

    Report Number
    1644487-2011-00965
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 16, 2007
    Report Date
    April 5, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NEUROSURGEON THAT A VNS PT UNDERWENT SURGERY FOR GENERATOR REPLACEMENT DUE TO EOS. AT THE SURGERY, THE SURGEON IMPLANTED THE NEW GENERATOR; HOWEVER, HE RECEIVED HIGH IMPEDANCE. HE ALSO REPORTED THAT HE VISUALIZED FLUIDS IN THE LEAD OF VNS SYSTEM. THE NEUROSURGEON CHOSE NOT TO PROCEED SINCE PT'S OPINION WAS NEEDED; HOWEVER, THE NEW VNS GENERATOR WAS TURNED OFF. IT IS UNK AT THIS TIME IF PT WILL HAVE SURGERY IN THE FUTURE. THE REVIEW OF PROGRAMMING HISTORY SHOWED THAT HIGH IMPEDANCE HAD OCCURRED (B)(6) 2007, BUT THE PT WAS NOT REFERRED FOR REVISION UNTIL RECENTLY. THE TREATING NEUROLOGIST'S NURSE WAS NOT AWARE OF HIGH IMPEDANCE ISSUE AND MANUFACTURER PROVIDED TRAINING TO HER. SHE STATED THAT NO MANIPULATION OR TRAUMA HAD OCCURRED AND PT WAS NOT REFERRED FOR X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS INC 300-20 3248

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR