BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 429446 · Received November 21, 2002

    Report

    Report Number
    1644487-2002-00512
    Event Type
    Injury
    Date Received
    November 21, 2002
    Date of Event
    October 1, 2002
    Report Date
    October 10, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PATIENT'S NCP SYSTEM WAS EXPLANTED DUE TO ABSCESS AND INFECTION. THE PATIENT WAS ORIGINALLY SCHEDULED FOR VNS IMPLANT IN 2002, BUT AFTER OPENING UP THE PATIENT IN THE OPERATING ROOM, THE SURGERY WAS ABORTED AND THE PATIENT WAS NOT IMPLANTED WITH THE NCP SYSTEM AT THAT TIME BECAUSE OF AN ISSUE WITH WRITTEN CONSENT. THE PATIENT WAS LATER IMPLANTED WITH THE NCP SYSTEM AFTER WHICH THE NECK INCISION WAS NOT HEALING PROPERLY. BETWEEN 10/02 AND 2 WEEKS LATER, PHYSICIAN NOTICED WHAT WAS REPORTED TO BE MSRA INFECTION FORMING AT THE NECK SITE AND THE PATIENT HAD ALSO DEVELOPED AN ABSCESS IN THE LEFT BREAST. PHYSICIAN ATTEMPTED TO DRAIN THE ABSCESS, BUT THEN DECIDED THAT IT WAS BAD ENOUGH TO WARRANT EXPLANT OF THE NCP SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 5757

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R DATE OF MFG 12/19/01, STERILIZATION LOT NO. 4813.| MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE 12/31/03