BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3160287 · Received June 10, 2013

    Report

    Report Number
    2182208-2013-01822
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 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

    PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE DEVICE WAS MECHANICALLY INTACT, AND THE DEVICE PASSED ALL INCOMING FUNCTIONAL TESTS. BATTERY WAS NEARLY DEPLETED, THE BACK UP BATTERY WAS REPLACED AS A RESULT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SALES REPRESENTATIVE (SR) THAT THE ANALYZER WOULD NOT CONNECT WITH THE PROGRAMMER; THE CONNECTION HAD BEEN LOST. THE SR RESTARTED THE SESSION, BUT THE PROBLEM REMAINED. THE SR THEN TOOK OUT THE ANALYZER AND REINTRODUCED IT AGAIN, BUT THAT DID NOT FIX THE ISSUE EITHER. THE ANALYZER WAS REPLACED WITH A DIFFERENT ONE AND THE ISSUE WAS RESOLVED. THE ANALYZER HAS BEEN RETURNED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259371 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2290

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER