BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2200871 · Received August 8, 2011

    Report

    Report Number
    1644487-2011-01803
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6), 2011 WHEN THE PHYSICIAN REPORTED THAT IT IS UNKNOWN WHETHER THE PATIENT HAS A PRIOR HISTORY OR A FAMILY HISTORY OF CARDIAC EVENTS. THE PATIENT WAS NOT HOSPITALIZED NOR WAS THE HOSPITALIZATION PROLONGED AS A RESULT OF THE ARRHYTHMIA. THE PHYSICIAN REPORTED THAT THE PATIENT HAS SEIZURES WITH SEVERE MENTAL IMPAIRMENT AND THAT THE PATIENT HAD A PROLONGED/DIFFICULT BIRTH. THE PATIENT'S VNS HAS BEEN PROGRAMMED ON SINCE THE ARRHYTHMIA EVENT WITH NO RECURRENCE OF ARRHYTHMIA.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE ANESTHESIOLOGIST REPORTED THAT THE VNS PATIENT WAS EXPERIENCING BRADYCARDIA DURING SYSTEM DIAGNOSTICS PERFORMED DURING THE INITIAL IMPLANT SURGERY. THE PATIENT'S HEART RATE DROPPED FROM 85 BPM TO 57 BPM. THE ANESTHESIOLOGIST AND SURGEON BELIEVED THAT THE ARRHYTHMIA WAS RELATED TO VNS STIMULATION DURING THE SYSTEM DIAGNOSTICS TEST, BUT NO INTERVENTION WAS TAKEN SINCE THE PATIENT'S HEART RATE RETURNED TO NORMAL. THE IMPLANT WAS CONTINUED AND THE DEVICE WAS FUNCTIONING PROPERLY. SYSTEM DIAGNOSTIC RESULTS WERE OUTPUT = OK/LEAD IMPEDANCE = OK/LEAD IMPEDANCE = 1578 OHMS/ERI = NO. THE ANESTHESIOLOGIST REPORTED THAT HE WASN'T CONCERNED ABOUT THE SEVERITY OF THE BRADYCARDIA BECAUSE IT WAS A MINIMAL/SHORT LIVED DROP. THE PATIENT'S GENERATOR WAS LEFT PROGRAMMED OFF. IT IS UNKNOWN AS TO WHETHER PATIENT HAS A HISTORY OF CARDIAC EVENTS, A FAMILY HISTORY OF CARDIAC EVENTS, OR IF THE PATIENT WAS ON ANY MEDICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 3011

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention