BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1232205 · Received November 14, 2008

    Report

    Report Number
    1644487-2008-02762
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    July 7, 2008
    Report Date
    October 15, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED TO A MANUFACTURE CONSULTANT THAT THEIR PATIENT WAS EXPERIENCING POSTOPERATIVE BRADYCARDIA. THE PATIENT HAD A BATTERY CHANGE 2008. THE BRADYCARDIA DEVELOPED FIVE MONTHS LATER. THEY SENT THE PATIENT HOME WITH A HOLTER MONITOR THE FOLLOWING MONTH. THEY TURNED VNS OFF BEFORE IN THE SAME MONTH, AND SHE WAS STILL EXPERIENCING BRADYCARDIA. SHE HAD NO PRE-EXISTING CARDIAC ISSUES. HER SEIZURES HAVE INCREASE TO PRE-VNS BASELINE SINCE THE DEVICE WAS TURNED OFF, SO THEY HAVE ADJUSTED HER MEDICATIONS. THE TREATING PHYSICIAN BELIEVES THAT THERE IS A DIRECT CORRELATION BETWEEN VNS AND THE BRADYCARDIA EVEN THOUGH THE DEVICE IS OFF. THE PATIENT'S MAX HEART RATE WAS 55-60 BPM AND IS NOW 44 BPM. THE BRADYCARDIA IS ONLY EXPERIENCED AT NIGHT (DURING SLEEP). AT THIS TIME, THERE ARE NO PLANS FOR EXPLANT OR TO TURN THE DEVICE BACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200616

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R