BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NBIH BIPOLAR PACING ELECTRODE CATHETER

    MDR report key: 2612706 · Received June 6, 2012

    Report

    Report Number
    1222791-2012-00001
    Event Type
    Injury
    Date Received
    June 6, 2012
    Date of Event
    April 30, 2012
    Report Date
    May 14, 2012
    Manufacturer
    C.R. BARD INC. (BEP)
    Product Code
    LDF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE SAME PROCEDURE, TWO TEMPORARY PACING ELECTRODE CATHETERS WERE FOUND TO BE "TOO SHORT" FOR FEMORAL ACCESS; AND THEREFORE, THEY HAD TO USE THE JUGULAR ACCESS. FURTHERMORE, THE CUSTOMER REPORTED THAT THE DISTAL ELECTRODE ON ONE OF THE CATHETERS WAS NONCONFORMING AND PREVENTED THE INTRODUCTION OF THE CATHETER THROUGH THE INTRODUCER. THE CUSTOMER DOES NOT KNOWN WHICH LOT NUMBER IS RELATED TO THE NONCONFORMING DISTAL ELECTRODE PROBLEM. IN ADDITION, ONLY ONE DEVICE IS AVAILABLE FOR ANALYSIS AND THE LOT NUMBER OF THIS DEVICE IS UNKNOWN. ON (B)(6) 2012, NEW INFO RECEIVED REPORTED THAT THE PT NEEDED A "STIMULATION URGENTLY" AND IT WAS IMPOSSIBLE TO USE THE DEVICE DUE TO THE SHORTER LENGTH. AT THIS TIME, THE DEVICE HAS NOT BEEN RECEIVED BY THE MFR TO PERFORM AN EVAL. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER 1222791-2012-00002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NBIH BIPOLAR PACING ELECTRODE CATHETER LDF C.R. BARD INC. (BEP) GFUH3545

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention