BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1033378 · Received April 23, 2008

    Report

    Report Number
    1644487-2008-00999
    Event Type
    Injury
    Date Received
    April 23, 2008
    Report Date
    March 24, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFG RECORDS WERE REVIEWED. REVIEW OF THE MFG RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RPTR INDICATED THAT A VNS PT EXPERIENCED AN INFECTION REQUIRING EXPLANTATION OF THE GENERATOR IN 2007. THE LEAD WAS LATER EXPLANTED DUE TO INFECTION IN 2008. THE TREATING MEDICAL PROFESSIONAL INDICATED THAT THE CAUSE OF THE INFECTION WAS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R