BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3990816 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02220
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    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 COULD NOT CONFIRM THE REPORTED EVENT. IT WAS NOTED THAT THE DISPLAY DROPS, THE ELECTROCARDIOGRAM (ECG) CONNECTOR WAS LOOSE ON THE LINK ELECTRONIC MODULE (LEM) CIRCUIT BOARD, BOTH DISPLAY LATCH HASPS WERE BROKEN, BOTH KEYBOARD HINGES WERE BROKEN, THE SYSTEM FAN WAS INTERMITTENTLY NOISY, AND THE RETENTION SPRING WAS BROKEN AND NEEDED TO BE REPLACED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 2290 PACING SYSTEM ANALYZER. 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 WHILE USING THE PROGRAMMER DURING A CASE, THE CALLER COULD NOT GET AN ATRIAL IMPEDENCE UNLESS THE VENTRICULAR PORT WAS USED. WHEN THE CALLER SWITCHED THE STERILE PACER CABLE TO THE VENTRICULAR SIDE OF THE ADAPTER AND LEFT THE ATRIAL PACING FUNCTION ON, THE RATE WAS VERY FAST UNTIL THE ATRIAL PACING OPTION ON THE PROGRAMMER WAS TURNED OFF. THE FAST RATE STOPPED WHEN THE RV LEAD PACED AT THE APPROPRIATE RATE. THE PROGRAMMER HAS BEEN RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468847 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 PROGRAMMER RADIO FREQUENCY (RF) HEAD