BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2811744 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03710
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 18, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    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 FOUND THAT THE HANDLE WAS BROKEN ON THE LOWER CASE, THREE HINGE PLATE SCREWS WERE MISSING, THE POWER CORD DOOR WAS DAMAGED, THE KEYBOARD LATCH AND CASE HINGES WERE BROKEN AND THE ELECTROCARDIOGRAM (ECG) CONNECTOR WAS LOOSE. (B)(4): ANALYSIS FOUND THAT THE CABLE WAS OUT OF ELECTRICAL SPECIFICATION, THIS CONFIRMED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY COULD NOT BE OBTAINED WITH IMPLANTABLE DEVICES. CHANGING THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD SEVERAL TIMES DID NOT RESOLVE THE ISSUE. IT WAS SUSPECTED THE RF HEAD CONNECTOR ON THE PROGRAMMER WAS THE CAUSE OF THE ISSUE. THE PROGRAMMER AND RF HEAD WERE RETURNED FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAMMER RF HEAD KRG MEDTRONIC, INC. 2067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2290 PACING SYSTEM ANALYZER