BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3864742 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00890
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 29, 2002
    Report Date
    January 30, 2002
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    Removal / Correction Number
    Z-1661-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATELY 6 WEEKS AGO, A FIELD CORRECTIVE ACTION WAS INITIATED FOR THE SUSPECT MEDICAL DEVICE NOTED IN SECTION D WHICH MAY INVOLVE INTERMITTENT PERFORMANCE OF CERTAIN PACING FUNCTIONS. THE INITIAL REPORT WAS ORIGINALLY SUBMITTED UNDER REPORT #2183613000-2002-00001 FROM A LEGACY SYSTEM. DUE TO SYSTEM LIMITATIONS, THIS SUPPLEMENTAL REPORT COULD NOT BE LINKED TO THE INITIALLY SUBMITTED REPORT.

    Description of Event or Problem · 1

    THE EXTERNAL PULSE GENERATOR (EPG) SUDDENLY PACED AT 180PPM (PULSES PER MINUTE) WHILE THE RATE WAS SET AT 80PPM. THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA AND WAS CODED. RESCUE WAS SUCCESSFUL, AND THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338275 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Life Threatening| R