BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4160853 · Received October 10, 2014

    Report

    Report Number
    2183613-2014-01180
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 24, 2014
    Report Date
    August 6, 2014
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT UPPER CASE AND ATRIAL OUTPUT CONNECTOR WERE BROKEN. ANALYSIS ALSO FOUND THAT THE UPPER AND LOWER CASES, SIDE BAIL COVERS AND RING COVER WERE BROKEN, THAT THE BATTERY RELEASE, RING AND BATTERY DRAWER WERE CONTAMINATED AND THE BATTERY CONTACTS WERE COMPRESSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD A CRACKED FRONT CASING AND ATRIAL CONNECTOR. THE GENERATOR WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641710 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA INC. 5388X

    Patients

    Seq Age Sex Outcome Treatment
    1