BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4162459 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-03079
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 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 CONFIRMED THE REPORTED EVENT, AS A RESULT THE LINK ELECTRONIC MODULE (LEM) CIRCUIT BOARD WAS REPLACED AND CALIBRATED. IT WAS ALSO NOTED THAT THE POWER CORD BAY WAS BROKEN.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: 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 THE PROGRAMMER BOOTED UP TO AN ERROR MESSAGE. THE PROGRAMMER WAS CYCLE POWERED AND THE ERROR CLEARED. THE PROGRAMMER WAS THEN USED WITH A PATIENT AND HAD TO BE CYCLE POWERED 4 TIMES IN ORDER TO COMPLETE THE INTERROGATION; NO OTHER PROGRAMMER WAS AVAILABLE TO USE. TECHNICAL SUPPORT (TS) STATED THAT IT WAS MOST LIKELY DUE TO A FAILING LINK ELECTRONICS MODULE (LEM) BOARD THAT HAS NOT FAILED COMPLETELY AND THE PROGRAMMER SHOULD BE RETURNED FOR REPAIR. THE PROGRAMMER HAS BEEN RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639784 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

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