BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4832720 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-02113
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 20, 2015
    Report Date
    March 25, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; LCD (LIQUID CRYSTAL DISPLAY) WAS MISSING SEGMENTS. ANALYSIS ALSO FOUND THE UPPER CASE, LOWER CASE BROKEN, TWO SIDE BAIL COVERS, AND BATTERY DRAWER WERE BROKEN. BATTERY CONTACTS WERE COMPRESSED, TWO CONTROL KNOBS WERE MISSING, AND KEYBOARD PAD WAS SCRATCHED (COSMETIC). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS DEFECTIVE. FOLLOWUP INDICATES THE LOWER DISPLAY WAS ILLEGIBLE (VERTICAL VOIDS). THE DEVICE WAS RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374515 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1