BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2791482 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03520
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 16, 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 LOW VOLTAGE DIFFERENTIAL SIGNALING PRINTED CIRCUIT BOARD WAS LOOSE. IT WAS ALSO NOTED THAT THE RIGHT ANTENNA WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY SCREEN OF THE PROGRAMMER WAS WAVY, AND WHEN IT WAS TURNED OFF, THE PROGRAMMER WOULD NOT REBOOT. IT WAS RETURNED FOR SERVICE. IT WAS INDICATED ON THE RETURN PAPERWORK THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH 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