BEUDAMED
    FDA Adverse Event Other Summary report: N

    CYBERONICS NEUROCYBERNETIC PROSTHESIS (NCP)

    MDR report key: 308227 · Received December 6, 2000

    Report

    Report Number
    1644487-2000-00024
    Event Type
    Other
    Date Received
    December 6, 2000
    Date of Event
    October 26, 2000
    Report Date
    November 6, 2000
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED WITH NCP SYSTEM. SIX WEEK CHECKUP DID NOT REVEAL ANY PROBLEMS. APPROXIMATELY ONE MONTH AFTER SIX WEEK CHECKUP, IT WAS NOTED THAT THE DEVICE HAD ERODED THROUGH THE SKIN. THE GENERATOR WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYBERONICS NEUROCYBERNETIC PROSTHESIS (NCP) NEUROSTIMULATOR LYJ CYBERONICS, INC. 101 37811C

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other BIPOLAR LEAD.