BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2260342 · Received September 22, 2011

    Report

    Report Number
    1644487-2011-02241
    Event Type
    Injury
    Date Received
    September 22, 2011
    Date of Event
    August 25, 2011
    Report Date
    August 26, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ALL ATTEMPTS FOR RETURN OF THE EXPLANTED VNS GENERATOR HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    CLINICAL NOTES WERE RECEIVED TO THE MANUFACTURER INDICATING A PATIENT WAS TO HAVE VNS GENERATOR REPLACEMENT SURGERY DUE TO NORMAL END OF SERVICE. THE NOTES DOCUMENTED THAT THE PATIENT HAS SLEEP APNEA. ALL ATTEMPTS TO THE REPORTER FOR ADDITIONAL INFORMATION AS TO THE RELATIONSHIP OF THE SLEEP APNEA TO THE VNS HAVE BEEN UNSUCCESSFUL TO DATE. ATTEMPTS FOR RETURN OF THE EXPLANTED GENERATOR ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 200727

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention