BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 786123 · Received November 21, 2006

    Report

    Report Number
    1644487-2006-00432
    Event Type
    Injury
    Date Received
    November 21, 2006
    Date of Event
    January 1, 2006
    Report Date
    October 25, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6: REVIEW OF X-RAYS BY MANUFACTURER DID NO REVEAL ANY OBVIOUS DISCONTINUITIES IN THE NCP SYSTEM; DIAGNOSTICS TESTS PERFORMED ON GENERATOR BY REPORTER INDICATED NORMAL NCP SYSTEM FUNCTIONING. THE RECENT INCREASE IN VNS THERAPY PARAMETERS AND THE PATIENT'S SIGNIFICANT NEUROLOGICAL DISEASE CONTRIBUTED TO THE BRADYCARDIA. HOWEVER, REPORTER FEELS VNS THERAPY IS BENEFICIAL FOR THIS PATIENT DESPITE THE BRADYCARDIA. HEART RATE AND RHYTHM CHANGES ARE POTENTIAL ADVERSE EVENTS OF VNS THERAPY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PATIENT WAS HOSPITALIZED FOR INCREASED SEIZURES. RECENTLY, THE VNS SETTINGS HAD BEEN TURNED UP. BRADYCARDIA WAS NOTED TO BE ASSOCIATED WITH STIMULATION AND THE NCP SYSTEM WAS DISABLED. THE BRADYCARDIA IMPROVED, BUT NOT TO PATIENT'S NORMAL HEART RATE. DURING THE HOSPITALIZATION, THE PATIENT'S SEIZURES INCREASED AND THE NCP SYSTEM WAS SLOWLY TITRATED UP TO A THERAPEUTIC LEVEL FOR INCREASED SEIZURE CONTROL. THE PATIENT WAS LATER RELEASED AND CONTINUES TO RECEIVE VNS THERAPY AND MAINTAIN SEIZURE CONTROL. THE PATIENT'S HEART RATE IS NO LONGER BRADYCARDIC, BUT IS LOWER THAN HIS NORMAL BASELINE. THE REPORTER HAS STATED VNS THERAPY IS BENEFICIAL TO THIS PATIENT DESPITE THE PATIENT'S FIVE-YEAR HISTORY OF BRADYCARDIA. NO SERIOUS INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other