BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 359524 · Received October 26, 2001

    Report

    Report Number
    1644487-2001-00583
    Event Type
    Injury
    Date Received
    October 26, 2001
    Date of Event
    September 27, 2001
    Report Date
    September 28, 2001
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PATIENT PRESENTS WITH REDNESS AND SWELLING IN THE NECK AREA AFTER "VNS" REPLACEMENT SURGERY DUE TO END OF SERVICE. A LUMP WAS NOTED IN 2001 THAT WAS NOT PRESENT THE DAY BEFORE. PHYSICIAN PLANS TO TAP THE LUMP AND RUN CULTURES IF HE GETS BLOOD FROM IT, AND EXPLANT IF HE GETS PUS. FURTHER INVESTIGATION REVEALED THAT THE DEVICE WAS EXPLANTED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48349 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 3673

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R LOT NO. 10179C. IMPLANTED 1998.| MODEL 300-20 NCP BIPOLAR LEAD. EXPIR DATE| 04/30/2000, DATE OF MFG 04/15/1998, STERILIZATION