BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3864849 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00889
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    October 22, 2002
    Report Date
    December 16, 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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATELY 6 WEEKS AGO, A FIELD CORRECTIVE ACTION WAS INITIATED FOR THE SUSPECT MEDICAL DEVICE WHICH MAY INVOLVE INTERMITTENT PERFORMANCE OF CERTAIN PACING FUNCTIONS. THE INITIAL REPORT WAS ORIGINALLY SUBMITTED UNDER REPORT (B)(4) 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

    PATIENT WITH PRINCIPAL DIAGNOSIS OF PERIPHERAL VASCULAR DISEASE, ATRIAL FLUTTER AND CHF (CONGESTIVE HEART FAILURE) UNDERWENT CARDIOVERSION (B)(6) 2002, WITH INSERTION OF TEMPORARY PACEMAKER SYSTEM. ON (B)(6) 2002, PATIENT COMPLAINED OF PALPITATIONS. NURSE FOUND EXTERNAL PACER WITH THE PROTECTIVE PLASTIC COVER IN THE DOWN POSITION AND THE HEART RATE DIAL AT 180BPM (BEATS PER MINUTE). PATIENT DISPLACED THE COVER INADVERTENTLY WHILE REPOSITIONING SELF IN BED. PACER WAS RESET TO CORRECT SETTING AND PATIENT WAS WITHOUT COMPLICATIONS. PERMANENT PACER PLACED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338563 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1