BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3862131 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01686
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    April 17, 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: ANALYSIS FOUND THE RF (RADIO FREQUENCY) HEAD WAS NOT ABLE TO INTERROGATE AND FAILED UPLINK FUNCTIONAL TESTS. RF HEAD CABLE FOUND TWISTED NEAR THE BASE OF THE RF HEAD; RF HEAD CABLE FOUND OUT OF SPECIFICATION. ANALYSIS ALSO FOUND THE TOP RF HEAD LENS HAS A CRACK. (B)(4).

    Description of Event or Problem · 1

    THE RF (RADIO FREQUENCY) HEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341977 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. R2067L

    Patients

    Seq Age Sex Outcome Treatment
    1