BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152160 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01171
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM TELEMETRY LIGHTS FLASHED ON AND OFF OR THAT THE PROGRAMMER TURNS OFF. THE COMMON MODE/WRIST ELECTRODE FUNCTIONAL TESTS WERE FOUND OUT OF SPECIFICATION. ANALYSIS FOUND A LOOSE ECG (ELECTROCARDIOGRAM) CONNECTOR ON A PRINTED CIRCUIT BOARD ASSEMBLY. ANALYSIS ALSO CONFIRMED THE SYSTEM FAN WAS INTERMITTENTLY NOISY. THE KEYBOARD CONNECTOR WAS FOUND DAMAGED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY LIGHTS FLASH ON AND OFF, EVEN WITH NO DEVICE UNDER THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD. THE PHYSICIAN ALSO REPORTED THE PROGRAMMER TURNED OFF OR LOST TELEMETRY DURING NORMAL USE, BUT THE ISSUE COULD NOT BE REPRODUCED. IT WAS ALSO NOTED THE FAN WAS NOISY. THE PROGRAMMER AND RF HEAD WERE RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252246 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090AA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGRAMMER RF (RADIO-FREQUENCY) HEAD