BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152959 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00587
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 8, 2013
    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 AND CORRODED. IT WAS ALSO NOTED THAT THE HIGH RATE COVER, CAUTION LABEL, ONE SIDE BAIL COVER, ONE SIDE BAIL AND RING BAIL WERE MISSING, THE BATTERY DRAWER AND O-RING WAS CONTAMINATED, ONE SIDE BAIL COVER AND RING COVER WERE BROKEN, THE HEART LEAD FLEX WAS CONTAMINATED, AND ONE KNOB AND SPRING WERE CONTAMINATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE FRONT AND BACK CASE ARE 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
    256126 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1