BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3993572 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01075
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 9, 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
    JA
    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 CONFIRMED THE REPORTED EVENT. THE PACING RATE WAS SET TO 30 BPM THEN THE DEVICE WAS TAPPED SLIGHTLY, THIS REPRODUCED THE 100 BPM OBSERVED ISSUE. OXIDATION ON THE BATTERY CONTACT SURFACE WAS NOT VISIBLE. THE FLEX TAPE AND SUBSTRATE OF THE DEVICE WERE CLEANED AND SUFFICIENT OPERATION OF THE DEVICE WAS VERIFIED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE EXTERNAL PULSE GENERATOR (EPG) WAS BEING USED ON A PATIENT DURING AN EMERGENCY PROCEDURE, PACING WAS SET AT 30 BPM, HOWEVER PACING WAS OBSERVED ON THE ECG MONITOR AT 100 BPM WHEN ATTEMPTING A PACING THRESHOLD TEST AFTER INSERTING A LEAD AND CONNECTING IT TO THE DEVICE. THE PHYSICIAN STOPPED USING THE EPG IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITH NO OTHER ISSUES USING ANOTHER EPG. THE EPG WAS RETURNED TO THE MANUFACTURER FOR SERVICING. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467862 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention