BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACEMAKER

    MDR report key: 8573449 · Received May 1, 2019

    Report

    Report Number
    MW5086322
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    April 28, 2019
    Report Date
    April 29, 2019
    Manufacturer
    BIOTRONIK
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BIOTRONIK PACEMAKER LEADS MALFUNCTIONING 2X IN THE LAST 2 YEARS, REQUIRING 2 PACEMAKER LEAD REVISIONS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361343 PACEMAKER IMPLANTABLE, PACEMAKER PULSE GENERATOR LWP BIOTRONIK
    361344 PACEMAKER IMPLANTABLE, PACEMAKER PULSE GENERATOR LWP BIOTRONIK INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization