BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 658049 · Received December 30, 2005

    Report

    Report Number
    1644487-2005-00916
    Event Type
    Malfunction
    Date Received
    December 30, 2005
    Report Date
    December 1, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR EXPLANTE WAS KNOWN AT THE TIME THAT SUPPLEMENTAL REPORT 1644487-2005-00916/01 WAS SUBMITTED, BUT WAS INDADVERTANTLY NOT INCLUDED IN THAT REPORT.

    Description of Event or Problem · 1

    THAT PATIENT UNDERWENT VNS THERAPY SYSTEM EXPLANT SURGERY, DURING WHICH BOTH THE LEAD AND GENERATOR WERE EXPLANTED. THE REASON FOR THE EXPLANT IS NOT KNOWN AT THIS TIME. WHEN A LEAD IS EXPLANTED, IT IS NORMALLY BECAUSE THERE IS A PRODUCT PROBLEM, USER ERROR, OR CLINICAL ADVERSE EVENT.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE NCP SYSTEM WAS EXPLANTED AT THE REQUEST OF THE PATIENT'S PARENTS AS THE PATIENT REPORTEDLY EXPERIENCED NO BENEFIT FROM THE VNS THERAPY. NO ALLEGATION OF MALFUNCTION WAS MADE AGAINST EITHER THE GENERATOR OR THE LEAD AND NO MALFUNCTION WAS NOTED DURING ANALYSIS OF EXPLANTED/RETURNED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD (INDICATION UNKNOWN) LYJ CYBERONICS, INC. 300-20 1708

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO