BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2032407 · Received March 28, 2011

    Report

    Report Number
    1644487-2011-00653
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    November 24, 2008
    Report Date
    February 28, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S VNS HAS BEEN DISABLED FOR MORE THAN 6 MONTHS AND THE PATIENT HAS NOW DEVELOPED HYPOTHERMIA (34 DEGREE CELSIUS) ONCE AGAIN. IT HAS BEEN DETERMINED THAT THE EVENT IS NOT VNS RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO OUR COUNTRY REP FROM A VNS TREATING PHYSICIAN IN (B)(6) THAT THEY HAD A VNS PT WHO HAD THREE INCIDENTS OF HYPOTHERMIA WITH THEIR VNS. THE VNS WAS PROGRAMMED OFF FOR SIX MONTHS AND THE EVENTS RESOLVED AFTER THE FIRST TWO EVENTS. THE VNS HAS BEEN PROGRAMMED BACK ON AND IS BEING SLOWLY TITRATED UP. NO PT MEDICATIONS WERE CHANGED PRECEDING THE EVENT. PRIOR TO THE EVENTS THE PT'S TEMPERATURE WAS NORMAL AND DURING EVENT WAS 29, 34.3 AND 33.6 DEGREES CELSIUS. THE EVENTS WERE ON: (B)(6) 2008, (B)(6) 2009, (B)(6) 2011. PRIOR TO THE ONSET OF THE EVENT IN (B)(6) 2011 THE PT'S THERAPY HAD BEEN RAISED TO 1MA OUTPUT CURRENT. WHEN THE EVENTS OCCURRED THE FIRST TIME THE TEMPERATURE NORMALIZED BY ITSELF. SECOND TIME THE STIMULATOR WAS PROGRAMMED TO 0,0 AND THE MOST RECENT TIME IN FEB THE PATIENT'S TEMPERATURE SPONTANEOUSLY RETURNED TO NORMAL WITHIN A 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200611

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention