BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 435492 · Received December 27, 2002

    Report

    Report Number
    1644487-2002-00545
    Event Type
    Injury
    Date Received
    December 27, 2002
    Date of Event
    November 1, 2002
    Report Date
    November 30, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PT HAD BEEN CHOKING EXCESSIVELY DUE TO STIMULATION. THE PT'S DEVICE WAS TURNED OFF USING THE MAGNET. THE PT WAS SEEN BY PHYSICIAN IN 12/02 AND THE PHYSICIAN TOLD THE PT'S PARENT THAT THE LEAD WAS DETACHED FROM THE GENERATOR. THE PHYSICIAN INDICATED THAT THE LEAD HAD MIGRATED TO THE CENTER OF THE PT'S NECK CAUSING THE PT TO CHOKE. THE PT'S PARENT INDICATED THAT THEY COULD SEE THE LEAD IN THE PT'S NECK WHEN THE PT LEANED THEIR HEAD BACK. THE PHYSICIAN PLANNED ON REMOVING THE NCP SYSTEM IN 2002, BUT THE PT DEVELOPED ASPIRATION PNEUMONIA IN 12/02; THEREFORE, THE SURGERY WAS CANCELLED. PHYSICIAN INDICATED THAT THE ASPIRATION PNEUMONIA WAS CAUSED BY THE CHOKING FROM THE NCP SYSTEM. THE PT WAS GIVEN ORAL ANTIBIOTICS FOR THE ASPIRTION PNEUMONIA AND THE PT'S DEVICE WAS PROGRAMMED TO OFF. SURGERY TO REMOVE THE NCP SYSTEM IS PLANNED FOR 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 23831C

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening| R EXPLANTED: 2001.| MODEL 101 NCP PULSE GENERATOR, EXP. DATE:| MODEL 100 NCP PULSE GENERATOR, IMPLANTED:| STERILIZATION LOT NO. 2702,| 9/30/2002, DATE OF MFG 4/2001,| IMPLANTED: 2001.