BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 2457071 · Received February 16, 2012

    Report

    Report Number
    1644487-2012-00412
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    April 1, 2011
    Report Date
    January 18, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: BEAL J, SOGAWA Y, CERESNAK S, MAHGEREFTEH J, MOSHE S. LATE ONSET ICTAL ASYSTOLE IN REFRACTORY EPILEPSY. PEDIATRIC NEUROLOGY 2011; 45: 253-255.

    Description of Event or Problem · 1

    AN ARTICLE TITLED 'LATE ONSET ICTAL ASYSTOLE IN REFRACTORY EPILEPSY" WAS RECEIVED AND REVIEWED BY THE MANUFACTURER ON (B)(6) 2012. THE ARTICLE DESCRIBES A MALE PATIENT WHO WAS IMPLANTED WITH A VNS SYSTEM. THE PATIENT DEVELOPED A RECURRENT ASYSTOLE AND SUBSEQUENTLY WAS IMPLANTED WITH A PACEMAKER. THE ARTICLE MENTIONS THAT, 10 MONTHS PRIOR TO THE INITIAL ASYSTOLE, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN EPISODE OF SUPRAVENTRICULAR TACHYCARDIA. THE ASYSTOLE OCCURRED DURING SEIZURES AND LASTED FROM 3-9 SECONDS. THERE WERE NO PRECEDING CHANGES IN HEART RATE. CARDIAC TELEMETRY ALSO REVEALED A PERSISTENT BASELINE BRADYCARDIA IN THE RANGE OF 50-65 BEATS PER MINUTE. WHEN THE GENERATOR WAS REPLACED DUE TO EOS, THE STIMULATOR WAS INITIALLY LEFT OFF TO DETERMINE THE EFFECTS OF STIMULATION ON THE PATIENT'S REPORTED ARRHYTHMIAS. IMPROVEMENTS WERE OBSERVED WITH THE PATIENT'S BRADYCARDIA; HOWEVER, THE EPISODES OF ASYSTOLE PERSISTED AND IT WAS DETERMINED THAT THERE WAS NOT A LINK BETWEEN THE VNS AND THE ASYSTOLE. THE GENERATOR WAS PROGRAMED ON, AND THE PATIENT WAS SUBSEQUENTLY IMPLANTED WITH A PACEMAKER. THE GENERATOR WAS THEN REMOVED DUE TO AN INFECTION, AND THE PATIENT WAS NOT RE-IMPLANTED. SIX MONTHS AFTER THE PLACEMENT OF THE PACEMAKER AND FOLLOWING THE REMOVAL OF THE VNS, THE PATIENT CONTINUES TO HAVE SEIZURES, AS WELL AS OCCASION EPISODES OF BRADYCARDIA. ATTEMPTS FOR ADDITIONAL INFORMATION REGARDING THE REPORTED HAVE BEEN UNSUCCESSFUL TO DATE. THE INFECTION IS REPORTED IN MEDICAL DEVICE REPORT # 1644487-2012-00415.

    Description of Event or Problem · 1

    REPORTER INDICATED THE ASYSTOLE EVENT WAS PREVIOUSLY REPORTED TO THE MANUFACTURER. PLEASE REFERENCE MDR REPORT # 1644487-2010-02110.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention