BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2792641 · Received October 16, 2012

    Report

    Report Number
    1644487-2012-02632
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A FAX WAS RECEIVED ON (B)(6) 2012, FROM THE PATIENT'S PHYSICIAN. THE FAX INDICATED THAT ADDITIONAL INTERVENTIONS INCLUDED "CARDIOLOGY CONSULT AND SIMULTANEOUS". THE PATIENT DID NOT HAVE A PREVIOUS HISTORY OR FAMILY HISTORY OF CARDIAC EVENTS. THE PATIENT'S PRE-EXISTING CONDITIONS INCLUDED NEONATAL CEREBRAL ABSCESSES, INFANTILE SPASMS, INTRACTABLE EPILEPSY, AND GLOBAL DEVELOPMENTAL DELAY. THE PATIENT EXPERIENCED BRADYCARDIA. PRIOR TO THE EVENT, THE PATIENT'S HEART RATE WAS 109 BPM. DURING THE EVENT, THE PATIENT'S HEART RATE WAS 104 BPM.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THIS VNS PATIENT EXPERIENCED AN ARRHYTHMIA DURING INITIAL IMPLANT SURGERY THAT DAY. THE PATIENT WAS SUCCESSFULLY IMPLANTED. AN IN-POCKET SYSTEM DIAGNOSTIC WAS NORMAL, AND A FINAL INTERROGATION CONFIRMED THAT THE NORMAL MODE AND MAGNET MODE OUTPUT CURRENTS WERE 0.00 MA. DURING THE FIRST SYSTEM DIAGNOSTIC TEST, THE SURGEON NOTICED A HEART ARRHYTHMIA DURING THE VNS STIMULATION PERIOD. HE STATED IT WAS NOT BRADYCARDIA, JUST AN ABNORMAL ARRHYTHMIA. THE SYSTEM DIAGNOSTIC TEST WAS REPEATED MULTIPLE TIMES, ALL TESTS WERE WITHIN NORMAL LIMITS, AND THE ARRHYTHMIA WAS STILL PRESENT. FOLLOWING EACH TEST, THE SURGEON ATTEMPTED TO RE-POSITION THE COILS ON THE NERVE TO MAXIMIZE THE DISTANCE BETWEEN THE COILS AND THE CERVICAL BRANCH OF THE VAGUS NERVE. HE STATED THE ARRHYTHMIA WAS MINIMIZED BUT WAS STILL PRESENT AFTER THE REPOSITIONING OF THE COILS. HE STATED THIS WAS LIKELY DUE TO THE VERY SMALL SIZE OF THE PATIENT AND THE SHORT LENGTH OF NERVE HE HAD TO WORK. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 201936

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other