BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 403683 · Received July 3, 2002

    Report

    Report Number
    1644487-2002-00314
    Event Type
    Injury
    Date Received
    July 3, 2002
    Date of Event
    February 1, 2002
    Report Date
    June 6, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PT'S GENERATOR WAS EXPLANTED DUE TO INFECTION. THE PT UNDERWENT GENERATOR REPLACEMENT SURGERY IN 2002 FOR END OF SERVICE. ON 02/2002, A DIFFERENT PHYSICIAN REMOVED THE PT'S STITCHES AND THE INCISION SITE STARTED TO OPEN. THE PT WAS SEEN BY NEUROLOGIST ON 02/2002 AND WAS PRESCRIBED ANTIBIOTICS. NEUROSURGEON LATER CHOSE TO EXPLANT THE GENERATOR. ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 4919

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE:| 03/31/2001, DATE OF MFG: 03/17/1999, STERILIZATION| LOT NO. 20644C.