BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4161608 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02657
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO CHEST PAIN AND WAS HOSPITALIZED. A DEVICE INTERROGATION FOUND THAT A LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED DUE TO AN ISOLATED HIGH IMPEDANCE MEASUREMENT OF 1000 OHMS AND THEN THE IMPEDANCE DROPPED BACK DOWN TO A BASELINE OF 494 OHMS. A FRACTURE WAS SUSPECTED. THE INTERROGATION ALSO NOTED OVERSENSING AND NOISE ON THE ELECTROGRAMS AND ONE HIGH THRESHOLD MEASUREMENT. THE LEAD PARAMETERS WERE REPROGRAMMED AND THE PATIENT WAS SCHEDULED FOR A LEAD REPLACEMENT. THE LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE PROGRAMMER HAD DIFFICULTY ESTABLISHING TELEMETRY AFTER THE INITIAL INTERROGATION. THE SOFTWARE WAS MANUALLY STARTED AND TELEMETRY WAS ESTABLISHED. THE PROGRAMMER REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641079 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR