BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860877 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00757
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    February 12, 2014
    Report Date
    March 14, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE LCD (LIQUID CRYSTAL DISPLAY) AND LCD LENS ARE BROKEN. ANALYSIS ALSO FOUND THE UPPER AND LOWER CASE HALVES ARE BROKEN. BATTERY RELEASE AND ONE BAIL ARE CONTAMINATED, BOTH BAIL COVERS ARE BROKEN, RING COVER IS INCORRECT PART, ONE CASE SCREW IS MISSING, VENTRICLE OUTPUT CONNECTORS LOCK IS BROKEN OFF, BATTERY CONTACTS ARE COMPRESSED, ONE BAIL IS BENT, RING IS BENT, AND BATTERY DRAWER IS DAMAGED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE HAS BEEN DROPPED AND DAMAGED, BROKEN DISPLAY. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343313 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1