BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4162873 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-03046
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 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

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT VERIFY THE REPORTED INTERROGATION ISSUE; PROGRAMMER WAS ABLE TO INTERROGATE WITH THE PROVIDED RF (RADIO FREQUENCY) HEAD AND A KNOWN GOOD RF HEAD. ALSO THE PROGRAMMER WAS ABLE TO INTERROGATE WIRELESSLY WITHOUT ISSUE. IT IS NOTED THE PROGRAMMER PASSED FUNCTIONAL TEST. ANALYSIS CONFIRMED THE TAB ON THE POWER CORD BAY DOOR WAS BROKEN. STYLUS WAS FOUND BROKEN.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT INTERROGATE PACEMAKERS. THE USER TRIED TO INTERROGATE PACEMAKERS FOR TWO PATIENTS AND ONE NON-IMPLANTED PACEMAKER, AND THE INTERROGATIONS WOULD NOT COMPLETE. ANOTHER PROGRAMMER WAS USED TO COMPLETE THE INTERROGATIONS. THE USER ALSO STATED THAT THE REAR DOOR OF THE PROGRAMMER HAD BROKEN TABS. THE PROGRAMMER HAS BEEN RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640470 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 PROGRAMMER RADIO FREQUENCY (RF) HEAD