BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 403710 · Received July 3, 2002

    Report

    Report Number
    1644487-2002-00308
    Event Type
    Injury
    Date Received
    July 3, 2002
    Date of Event
    January 13, 2002
    Report Date
    February 1, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE PT WAS DIAGNOSED WITH COMPLETE LEFT VOCAL CORD PARALYSIS BY AN EAR, NOSE AND THROAT PHYSICIAN. THE DEVICE HAD NOT YET BEEN PROGRAMMED TO ON. FURTHER FOLLOW-UP REVEALED THAT THE PT'S VOICE HAD RETURNED TO NORMAL ON 2/2002. THE PT'S DEVICE WAS PROGRAMMED TO ON IN 02/2002. THE PT WAS LAST SEEN BY NEUROLOGIST ON 2/2002 AND IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 40535C

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Disability 01/31/2002, DATE OF MFG: 07/28/2000, STERILIZATION| MODEL 101 NCP PULSE GENERATOR, EXP DATE:| LOT NO. 285.