BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNS THERAPY PULSE

    MDR report key: 557743 · Received December 5, 2004

    Report

    Report Number
    1644487-2004-01039
    Event Type
    Injury
    Date Received
    December 5, 2004
    Date of Event
    October 1, 2004
    Report Date
    November 5, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PT UNDERWENT NCP SYSTEM EXPLANT DUE TO STAPH AUREUS INFECTION. BOTH THE PULSE GENERATOR AND THE ENTIRE LEAD (INCLUDING ELECTRODES) WERE EXPLANTED. IT WAS REPORTED THAT THE NCP SYSTEM TUNNELING TOOL WAS NOT USED DURING IMPLANT SURGERY, BUT THAT A CLAMP WAS USED INSTEAD. THE INFECTION HAS REPORTEDLY RESOLVED. REVIEW OF MFG RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD CONFIRMED STERILIZATION OF DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE PULSE GENERATOR LYJ CYBERONICS, INC. 102 10464

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| R EXPIR DATE: 04/30/2006, DATE OF MFG 04/20/2004,| STERILIZATION LOT NO. 10539| MODEL 302-20 VNS THERAPY LEAD, EXPIR DATE: