BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2790262 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03438
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    May 21, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. EVALUATION SUMMARY: (B)(4): ANALYSIS CONFIRMED THE REPORTED EVENT. THE BLANK SCREEN IS RELATED TO A PRINTED CIRCUIT BOARD ASSEMBLY THAT WAS FOUND OUT OF ELECTRICAL SPECIFICATION. ERRORS LOGGED ON THE HARD DRIVE ARE CONSISTENT WITH A PRINTED CIRCUIT BOARD ASSEMBLY CALIBRATION ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCREEN WILL NOT COME ON. THE PROGRAMMER WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAM W/TELEMETRY C PROGRAMMER DXY MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2067 PROGRAMMER RF HEAD