BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1852350 · Received September 29, 2010

    Report

    Report Number
    1644487-2010-02201
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    July 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A VNS PATIENT'S MOTHER THAT THE PATIENT WHO WAS IMPLANTED WITH VNS IN (B)(6)2009, WAS SEDATED FOR A PROCEDURE ABOUT ONE MONTH AGO AND WHILE SEDATED, THE ANESTHESIOLOGIST INFORMED THE MOTHER THAT THE PATIENT HAD ARRHYTHMIA. THE PATIENT WENT TO A CARDIOLOGIST A WEEK LATER, AND AN ECHO CARDIOGRAM WAS PERFORMED WHICH INDICATED GOOD HEART FUNCTION HOWEVER, THE MEASUREMENTS WERE OFF A LITTLE. THE PATIENT WAS GOING TO FOLLOW UP WITH THE CARDIOLOGIST IN ABOUT 18 MONTHS. FOLLOW UP WITH THE NEUROLOGIST REVEALED THAT IT WAS UNK WHETHER OR NOT THE ARRHYTHMIA WAS RELATED TO VNS. THE ARRHYTHMIA DID NOT OCCUR WITH STIMULATION. THERE WERE NO CAUSAL OR CONTRIBUTORY MEDICATION OR PROGRAMMING CHANGES PRIOR TO THE ONSET OF THE ARRHYTHMIA. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200983

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention