BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASERPOR 030-236

    MDR report key: 77763 · Received March 15, 1997

    Report

    Report Number
    1316542-1997-00586
    Event Type
    Malfunction
    Date Received
    March 15, 1997
    Date of Event
    December 22, 1995
    Report Date
    March 14, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UNIT WAS CUT & CAPPED DUE TO A REPORT OF HIGH THRESHOLD AT THE TIME OF A PACEMAKER REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASERPOR 030-236 Implant CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE DTB TELECTRONICS PACING SYSTEMS 030-236 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention