BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860313 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00784
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    February 7, 2014
    Report Date
    March 5, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE UPPER AND LOWER CASES WERE BROKEN. IT WAS ALSO NOTED THAT THE HIGH RATE COVER WAS BROKEN, THE MAIN CLEAR COVER WAS MISSING, BOTH BAIL COVERS WERE MISSING, ONE CASE SCREW WAS MISSING, BOTH BAILS WERE MISSING AND THE BATTERY DRAWER WAS BROKEN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CASE IS DAMAGED. THE DEVICE WAS RETURNED FOR REPAIR AND CALIBRATION. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342126 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1