BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2790164 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03428
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4): ANALYSIS FOUND THAT THERE WAS INTERMITTENT TELEMETRY DUE TO A LOOSE RADIOFREQUENCY (RF) HEAD CONNECTOR ON THE PROGRAMMER PRINTED CIRCUIT BOARD. IT WAS ALSO NOTED THAT THE KEYBOARD CABLE WAS DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER "TAKES TOO LONG" TO DOWNLOAD FROM THE DEVICE. THE PROGRAMMER HEAD WAS CHANGED OUT BUT THE SITUATION DID NOT IMPROVE. THE PROGRAMMER WAS RETURNED FOR SERVICE. 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| 2290 PACING SYSTEM ANALYZER