BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152343 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00682
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    March 21, 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
    HEALTH PROFESSIONAL

    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 MAIN COVER WAS MISSING AND THE LOWER CASE WAS BROKEN. IT WAS ALSO NOTED THAT THE HIGH RATE COVER WAS BROKEN, THE UPPER CASE WAS BROKEN AND CONTAMINATED, THE BATTERY DRAWER WAS OUT OF SPECIFICATION, THE RING COVER WAS BROKEN, THE TWO SIDE BAIL COVERS WERE CONTAMINATED AND THE RING WAS BENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CASE IS BROKEN AND THE COVER IS MISSING. THE DEVICE WAS RETURNED FOR REPAIR. 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
    252898 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1