BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860105 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00798
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    February 10, 2014
    Report Date
    March 18, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 COULD NOT CONFIRM THE REPORTED EVENT; DEVICE PASSED ALL INCOMING FUNCTIONAL TESTS. ANALYSIS FOUND UPPER CASE, LOWER CASE, AND BATTERY DRAWER ARE BROKEN. BATTERY RELEASE, HEART BLOCK, LEAD FLEX COVER, HEART WIRE CONTACTS, AND BATTERY FLEX ARE CONTAMINATED. TWO SIDE BAIL COVERS ARE BROKEN/MISSING. RING COVER, TWO CASE SCREWS, RING COVER SCREW, TWO SIDE BAILS, RING, AND BATTERY DRAWER O-RING ARE MISSING. BATTERY CONTACTS COMPRESSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS DROPPED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND CALIBRATION, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339917 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1