BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2202128 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01200
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 19, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    Removal / Correction Number
    ASKU
    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. TELEMETRY WAS INTERMITTENT. THE PRINTED CIRCUIT BOARD AND ANTENNA WERE FOUND TO BE OUT OF SPECIFICATION. THE CASE HANDLE WAS ALSO NOTED TO BE BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY WAS POOR OR INTERMITTENT WITH DEVICES. PRESSURE ON THE PROGRAMMER RF HEAD CONNECTOR WOULD SOMETIMES HELP ESTABLISH TELEMETRY. THE PROGRAMMER HEAD WAS REPLACED, WITH NO CHANGE. BOOT UP WAS ALSO SLOW. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other