BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3992674 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02376
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 20, 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

    CORRECTION: FURTHER REVIEW PROMPTED A CHANGE IN THE EVALUATION CONCLUSION. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THREE INPUT CONNECTOR SLOTS HAVE DAMAGED WIRES. ONE OF THE SLOTS HAS ONE WIRE BENT DOWN INSIDE THE SLOT POSSIBLY COMPROMISING THE CONNECTION. IT IS NOTED THE ANALYZER PASSED FUNCTIONAL TESTING AND PASSED A SYSTEMS TEST WITH A KNOWN GOOD PROGRAMMER.

    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 THREE INPUT CONNECTOR SLOTS HAVE DAMAGED WIRES. ONE OF THE SLOTS HAS ONE WIRE BENT DOWN INSIDE THE SLOT POSSIBLY COMPROMISING THE CONNECTION. (B)(4).

    Description of Event or Problem · 1

    THE ANALYZER 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
    470193 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 229047

    Patients

    Seq Age Sex Outcome Treatment
    1