BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2441348 · Received February 7, 2012

    Report

    Report Number
    1644487-2012-00308
    Event Type
    Injury
    Date Received
    February 7, 2012
    Date of Event
    July 1, 2011
    Report Date
    January 12, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINIC NOTES DATED (B)(6) 2011 AND RECEIVED BY THE MANUFACTURER ON (B)(6) 2012 THAT A PATIENT HAD A "SMALL HEART ATTACK" IN (B)(6) 2011 AND WAS HOSPITALIZED FOR FOUR DAYS AS A RESULT. DIAGNOSTIC TESTS WERE PERFORMED HOWEVER THE SPECIFIC TEST RESULTS WERE NOT PROVIDED. THE PATIENT WAS TOLD SHE WAS NOT A CANDIDATE FOR SURGERY AT THIS TIME. THE PATIENT WAS GIVEN NEW MEDICATIONS AND STOPPED SMOKING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE HEART ATTACK WAS NOT RELATED TO THE PATIENT'S VNS DEVICE OR THERAPY RATHER THE RESULT OF UNHEALTHY LIFESTYLE CHOICES. THE PATIENT WAS SMOKING AND WAS OBESE AND THESE TWO FACTORS ARE WHAT CAUSED THE HEART ATTACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 6182

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R