BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4163025 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-03026
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 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

    CORRECTED INFORMATION NO EVAL EXPLAIN CODE. 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. CONCOMITANT PRODUCT: 229047 ANALYZER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; PROGRAMMER WILL ONLY INTERROGATE WITH A RF (RADIO FREQUENCY) HEAD IF DOWNWARD PRESSURE IS APPLIED TO RF CONNECTOR. SOLDER JOINTS OF THE RF HEAD CONNECTOR FOUND CRACKED. IT WAS NOTED THE STYLUS IS MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER WILL NOT INTERROGATE WITHOUT MANIPULATION OF THE CONNECTION OF THE PROGRAMMER HEAD. PROGRAMMER HEAD WAS CHANGED MULTIPLE TIMES. WHEN TRYING TO PERFORM A DEVICE CHECK, NEED TO PUSH DOWN ON CONNECTOR TO KEEP CONNECTION WITH DEVICE. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639998 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD