BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EP MED SYSTEM

    MDR report key: 482168 · Received September 8, 2003

    Report

    Report Number
    482168
    Event Type
    Injury
    Date Received
    September 8, 2003
    Date of Event
    August 19, 2003
    Report Date
    August 26, 2003
    Manufacturer
    EP MED SYSTEM
    Product Code
    DTA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN EP LAB FOR AV NODE ABLATION AND PERMANENT PACEMAKER INSERTION. THE BATTERY IN THE PACING UNIT FAILED. THE PT'S HEARTRATE WAS 30. NO WARNING SIGNS OF "LOW BATTERY" WAS SEEN BY ANY OF THE STAFF. IT TOOK ABOUT 2 MINUTES TO CHANGE BATTERY. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EP MED SYSTEM PACER SONIC DTA EP MED SYSTEM PS6100F1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention