BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4970660 · Received August 5, 2015

    Report

    Report Number
    2182208-2015-02400
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    June 26, 2015
    Report Date
    June 29, 2015
    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 CUSTOMER COMMENT OF A LOOSE ELECTROCARDIOGRAM CONNECTION AND THEREFORE THE LINK ELECTRONIC MODULE BOARD WAS REPLACED AND CALIBRATED TO RESOLVE. ANALYSIS ALSO NOTED THAT THE POWER SUPPLY FAN WAS NOISY AND THE KEYBOARD WAS MISSING. BOTH WERE REPLACED.

    Additional Manufacturer Narrative · 1

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

    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 THE PROGRAMMER HAD A NOISY ELECTROCARDIOGRAM AND THAT THE CONNECTION/PORT WAS VERY LOOSE. THE PROGRAMMER WAS RETURNED DOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516381 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1