BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELECTRONICS

    MDR report key: 494583 · Received November 4, 2003

    Report

    Report Number
    MW1030044
    Event Type
    Injury
    Date Received
    November 4, 2003
    Date of Event
    June 17, 2003
    Report Date
    October 28, 2003
    Manufacturer
    ACCUFIX RESEARCH INSTITUTE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ATRIAL LEAD INPEDANCE: 12/2002 455 OHMS, 6/2003 >3200 OHMS. ATRIAL CAPTURE: 12-2002 1.8V @ 0.4 MS PW, 6-2003 NO CAPTURE AT 7.2 V. QUESTION LEAD FRACTURE? REF. TO DR. LEAD REMOVED WITH LASER EXTRACTOR IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELECTRONICS ATRIAL PACING LEAD DTB ACCUFIX RESEARCH INSTITUTE 330-801 ACCUFIX *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O