BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3991705 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-00977
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 THE LOWER CASE WAS BROKEN BUT WAS UNABLE TO CONFIRM THAT A SELF-TEST ERROR WAS GENERATED. ANALYSIS ALSO FOUND THAT THE UPPER CASE AND LEAD FLEX COVER WERE BROKEN, THAT THE RING COVER WAS CONTAMINATED AND THE KEYBOARD SCRATCHED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD A DAMAGED CASE AND ALSO GENERATED A SELF-TEST FAILURE MESSAGE. 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
    468153 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA INC. 5388X

    Patients

    Seq Age Sex Outcome Treatment
    1