BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 6287890 · Received January 30, 2017

    Report

    Report Number
    2183613-2017-00001
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Date of Event
    April 28, 2010
    Report Date
    April 29, 2010
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-1661-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FORM CODE: F77772. THESE EVENTS WERE REPORTED TO FDA ON (B)(6) 2017 WITHIN A RETROSPECTIVE SUMMARY REPORT. THE FDA APPROVAL NUMBER FOR THIS SUMMARY REPORT IS E2016027. THE TOTAL NUMBER OF EVENTS BEING SUMMARIZED FOR PRODUCT CODE LWP IS 3179, INCLUDING THE 3500A EVENT AND EVENTS DETAILED. THIS RETROSPECTIVE REVIEW WAS PERFORMED FOLLOWING OUR FIRM¿S CHANGE IN MEDICAL DEVICE REPORTING CRITERIA. THESE REPORTS REPRESENT EVENTS WITH ALERT DATES IN THE TWO YEARS PRIOR TO THAT CHANGE IN REPORTING CRITERIA. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. HOWEVER IT WAS NOTED THAT THE LOWER CASE WAS BROKEN, ONE BAIL COVER WAS BROKEN AND THE RING WAS BENT. FOR USE BY USER FACILITY/IMPORTER(DEVICES ONLY) (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SENSITIVITY WAS OFF AND THE SENSITIVITY KNOB NEEDS TO BE REPAIRED. THE DEVICE WAS RETURNED FOR SERVICING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70787 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1