BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2810292 · Received October 31, 2012

    Report

    Report Number
    1644487-2012-02749
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOW UP WITH THE PHYSICIAN FOUND THAT HE WAS UNABLE TO ANSWER ANY QUESTIONS REGARDING THE BRADYCARDIA. THE PHYSICIAN DID NOT FILL OUT THE ARRHYTHMIA QUESTIONNAIRE AS IT WAS STATED THAT NO ARRHYTHMIA WAS OBSERVED BY THE OFFICE. IT WAS UNKNOWN IF THE PATIENT HAD A MEDICAL HISTORY OF BRADYCARDIA; HOWEVER, IT WAS STATED THAT THE EKGS WAS CONSISTENT WITH SINUS BRADYCARDIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A PEDIATRICIAN CALLED TO REPORT THAT THEIR PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES, MUSCLE SPASMS, AND HAD A CLICKING NOISE EMANATING FROM HIS NECK. THESE EVENTS ARE ADDRESSED IN (MFR # 1644487-2012-02809). DURING THIS CALL IT WAS MENTIONED THAT THE PATIENT HAD MILD BRADYCARDIA. IT IS UNKNOWN AT THIS TIME IF THE BRADYCARDIA IS RELATED TO THEIR VNS THERAPY OR NOT, AS ALL ATTEMPTS HAVE BEEN MADE TO GET ADDITIONAL INFORMATION; HOWEVER, THEY HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200828

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR