BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5348 SINGLE CHAMBER

    MDR report key: 2183419 · Received July 14, 2011

    Report

    Report Number
    2183419
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    THE INCIDENT INVOLVED S MEDTRONIC EXTERNAL PACEMAKER HAVING TROUBLE "CAPTURING" ON A CATH LAB PATIENT. THIS PACEMAKER HAD TO BE TURNED UP TO 20MA TO CAPTURE. IT WAS REPLACED BY ANOTHER PACEMAKER WHICH WAS ABLE TO CAPTURE AT 10MA. THERE WAS NO SIGNIFICANT PATIENT IMPACT. BIOMED CONFIRMED THERE IS A SENSITIVITY PROBLEM AND THE PACEMAKER HAS BEEN SENT TO THE MANUFACTURER FOR REPAIR.====================== MANUFACTURER RESPONSE FOR PACEMAKER, EXTERNAL, MEDTRONIC (PER SITE REPORTER)======================RETURNED DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5348 SINGLE CHAMBER PACEMAKER, EXTERNAL DTE MEDTRONIC, INC. 5348 *

    Patients

    Seq Age Sex Outcome Treatment
    1 101 YR NONE KNOWN.