BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152538 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01544
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    March 19, 2013
    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 THAT THE DEVICE FAILED TELEMETRY TESTING DUE TO THE CABLE BEING OUT OF ELECTRICAL SPECIFICATION. IT WAS ALSO NOTED THAT THE LABEL WAS MISSING ITS COATING. CONCOMITANT PRODUCTS: PRODUCT ID 2090W PROGRAMMER; PRODUCT ID 229047 ANALYZER. (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS.

    Description of Event or Problem · 1

    THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252078 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1