BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX45JBP

    MDR report key: 226747 · Received May 28, 1999

    Report

    Report Number
    1028232-1999-00008
    Event Type
    Malfunction
    Date Received
    May 28, 1999
    Date of Event
    May 25, 1999
    Report Date
    May 25, 1999
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE LEAD WAS INTRODUCED USING THE STRAIGHT STYLET. ONCE THE LEAD WAS POSITIONED IN THE ATRIUM, THE STRAIGHT STYLET WAS REPLACED BY THE SCREWDRIVER STYLET. THE PHYSICIAN APPLIED GENTLE PRESSURE ON THE SCREWDRIVER STYLET TO ENGAGE THE HELIX MECHANISM. THE SCREW MECHANISM SEPARATED FROM THE LEAD AND FELL TO THE FLOOR OF THE ATRIUM. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE SCREW MECHANISM FROM THE PATIENT WITHOUT ANY ADVERSE EVENT. ANOTHER LEAD OF SIMILAR TYPE WAS IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX45JBP Implant LEAD, PACEMAKER DTB BIOTRONIK, INC. 124395 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention