BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2003729 · Received February 23, 2011

    Report

    Report Number
    1644487-2011-00325
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 25, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A PT WAS EXPERIENCING PAIN A THE VNS GENERATOR SITE. THE VNS WAS DISABLED BUT THE PAIN CONTINUED TO WORSEN AND THE PT WAS HOSPITALIZED. THE PT HAD NO KNOWN TRAUMA. THE PT THEN HAD VNS GENERATOR REPLACEMENT SURGERY PERFORMED FOR REPORTED "BATTERY MALFUNCTION." VNS DIAGNOSTICS WITH THE RESIDENT LEAD AND NEW GENERATOR WERE "OK" PER THE IMPLANT CARD RECEIVED BY THE MANUFACTURER. THE PAIN RESOLVED AFTER THE GENERATOR WAS REPLACED. THE EXPLANTED GENERATOR WAS RETURNED FOR ANALYSIS AND NO ANOMALIES WERE IDENTIFIED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200704

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R