BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3993310 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02325
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 9, 2014
    Report Date
    June 11, 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

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: DURING TESTING THE ANALYZER'S UNIPOLAR VENTRICLE IMPEDANCE WAS OUT OF SPECIFICATION, AND IT WAS FURTHER NOTED THAT THE ANALYZER WAS OUT OF SPECIFICATION ON MOST FUNCTIONAL TESTS. IT WAS DETERMINED THAT THE UNIT WAS NOT FUNCTIONAL AND NOT REPAIRABLE AND WAS TO BE SCRAPPED AND SAVED FOR FAILURE ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    THE ANALYZER WHICH WAS RETURNED WITH NO INFORMATION SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470324 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 229047

    Patients

    Seq Age Sex Outcome Treatment
    1