BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 521008 · Received April 16, 2004

    Report

    Report Number
    1644487-2004-00324
    Event Type
    Injury
    Date Received
    April 16, 2004
    Date of Event
    January 1, 2004
    Report Date
    March 19, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PT'S NCP SYSTEM WAS EXPLANTED BECAUSE "THE PT'S SYMPTOMS WITH THE VNS THERAPY WORSENED" AND THAT THERE WAS NOTHING WRONG WITH THE NCP SYSTEM. INVESTIGATION TO DATE HAS BEEN UNABLE TO DETERMINE WHETHER THE PT WAS AT RISK FOR SERIOUS INJURY WHILE RECEIVING VNS THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 1452

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| L| R EXPIR DATE 6/30/2002, DATE OF MFG 6/23/2000,| MODEL 300-20 NCP BIPOLAR LEAD,| STERILIZATION LOT NO. 40302C.