BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 2031352 · Received March 23, 2011

    Report

    Report Number
    1644487-2011-00616
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO OUR COUNTRY MANAGER IN (B)(6) THAT THERE WAS A VNS PT WHO DISPLAYS INTEROPERATIVE BRADYCARDIA DURING IMPLANTATION OF THEIR VNS. DURING INTRAOPERATIVE SYSTEM DIAGNOSTIC TESTING THE PT SHOWS A BRIEF HEART RATE REDUCTION. THE ANESTHESIOLOGIST DESCRIBED THIS EVENT AS FOLLOWS: THE BEGINNING OF SYSTEM DIAGNOSTIC: FROM 70 BEATS PER MINUTES TO 65, 55, 45 AND THEN RETURNED TO THE NORMAL 70 BEATS PER MINUTES AS INITIAL. DURING THE SECOND SYSTEM DIAGNOSTIC THE PT SHOWS ONLY REDUCTION FROM 70 BEATS PER MINUTE'S TO 65 AND THEN TO 55 AFTERWARDS IT RETURNED TO BASE FREQUENCY. NO OTHER CHANGES IN CARDIAC FREQUENCY WERE OBSERVED. AFTER DOING THIS TEST, PARAMETERS WERE SET TO THE DEFAULT STATUS. THE GENERATOR WAS PROGRAMMED WITH THE FOLLOWING PARAMETERS: 0.25MA OUTPUT CURRENT, FREQUENCY: 20 HZ, PULSE WIDTH: 250 USED, ON TIME 14 SECS, OFF TIME 30 SECONDS. THE PT WAS EVALUATED FOR 10 MINUTES WHERE THE PT DID NOT SHOW ANY CARDIAC FREQUENCY ALTERATION. THE PT WILL BE MONITORED AT UPCOMING VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 304 LYJ CYBERONICS, INC. 304 2844

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R