BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2131745 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-01016
    Event Type
    Malfunction
    Date Received
    June 16, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 COULD NOT CONFIRM THE REPORTED EVENT. INTERROGATION WITH TWO DIFFERENT PROGRAMMER RF HEADS WAS SUCCESSFUL. THE FLOPPY DISK DRIVE WAS FOUND TO BE INOPERATIVE, AND A SYSTEM ERROR HAD OCCURRED RECENTLY THREE TIMES. THE ANTENNA WAS ALSO FOUND TO BE OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER WOULD NOT INTERROGATE DEVICES. THE RF HEAD WAS REPLACED, WITH THE SAME RESULTS. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    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