BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151740 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00565
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 21, 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
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, DEVICE PASSED ALL FUNCTIONAL TESTS. IT WAS ALSO NOTED THAT THE UPPER CASE WAS DENTED AFFECTING KEYBOARD FIT, THE UPPER AND LOWER CASES WERE BROKEN AND CONTAMINATED, THE BATTERY RELEASE WAS CONTAMINATED, BOTH BAIL COVERS WERE MISSING, THE RING COVER WAS MISSING, THE BATTERY CONTACTS WERE COMPRESSED, BOTH BAILS WERE MISSING, THE RING WAS MISSING, THE BATTERY DRAWER WAS DAMAGED AND CONTAMINATED, AND THE KEYBOARD WAS SCRATCHED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT CAPTURE. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253186 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1