BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4160142 · Received October 10, 2014

    Report

    Report Number
    2183613-2014-01202
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 30, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE 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) LENS IS CRACKED, THE LCD IS OUT OF ELECTRICAL SPECIFICATION (MISSING PIXELS), AND THE KEYBOARD IS SCRATCHED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE HAS PHYSICAL CRACKS IN THE PROTECTIVE SCREEN COVERING THE TWO LCDS (LIQUID CRYSTAL DISPLAYS). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638006 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1