BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 434893 · Received December 23, 2002

    Report

    Report Number
    1644487-2002-00528
    Event Type
    Injury
    Date Received
    December 23, 2002
    Date of Event
    September 1, 2002
    Report Date
    October 8, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PT'S NCP SYSTEM WAS EXPLANTED DUE TO INFECTION AT THE LEAD SITE. IT WAS INITIALLY REPORTED THAT THE PT HAD CUT THEMSELVES AT THE NECK INCISION SITE WHILE SHAVING IN 8/2002. THE LEAD WAS REPORTEDLY VISIBLE AS A RESULT OF THE CUT, BUT THE WOUND SCABBED OVER AND HEALED. THE PT'S NCP SYSTEM EXPLANT WAS INITIALLY REPORTED TO BE DUE TO LACK OF EFFICACY AND NOT RELATED TO THE SHAVING EVENT. IT WAS LATER REPORTED THAT THE PT'S NCP SYSTEM WAS EXPLANTED DUE TO INFECTION AT THE LEAD AREA/NECK INCISION SITE AND THAT THE PT HAS SOME VOCAL CORD PARALYSIS. THE PT HAS REPORTEDLY BEEN REFERRED TO AN EAR, NOSE, THROAT AND SPEECH PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 2167

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R| S MODEL 101 NCP PULSE GENERATOR, S/N 09648| EXPIR DATE 8/31/2002, DATE OF MFG 3/13/2001,| STERILIZATION LOT NO. 2408