BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3991105 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01007
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-1661-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE BATTERY CONTACTS WERE CONTAMINATED, RATE INCREASE COULD NOT BE REPRODUCED. IT WAS NOTED THAT THE ACTUAL RATE AND OUTPUT DO NOT MATCH THE DIAL SETTING. AFTER OPENING THE DEVICE AND REMOVING THE INTERCONNECT FLEX TAPE FROM THE MAIN BOARD CONNECTOR AND CONNECTING IT BACK AGAIN, THE SETTINGS MATCH THE VALUES MEASURED WITH THE TESTER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE EXTERNAL PULSE GENERATOR (EPG) WAS CONNECTED TO A PATIENT, THE PACING RATE SUDDENLY INCREASED TO 180 BPM. THE PATIENT REMAINED ASYMPTOMATIC AND THE RATE WAS MANUALLY LOWERED TO 60 BPM UNTIL IT WAS EXCHANGED FOR ANOTHER EPG A FEW MINUTES LATER. THE EPG WAS IMMEDIATELY REMOVED FROM SERVICE AND RETURNED TO THE HOSPITAL MEDICAL PHYSICS DEPARTMENT FOR TESTING WHERE NO ISSUE COULD BE FOUND WITH IT. THE DEVICE WAS THEN RETURNED TO THE MANUFACTURER FOR SERVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468703 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348XK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention