BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3160303 · Received June 10, 2013

    Report

    Report Number
    2182208-2013-01805
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT. THE ANALYZER FAILED TESTING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN TRYING TO START AN ANALYZER SESSION WITH THE PROGRAMMER, THE PROGRAMMER DISPLAYED AN ERROR MESSAGE; THE CONNECTION BETWEEN THE ANALYZER AND PROGRAMMER HAD BEEN LOST. THE SESSION WAS RESTARTED, BUT THE PROBLEM REMAINED. THE ANALYZER WAS THEN TAKEN OUT AND REINTRODUCED, BUT THE ISSUE WAS NOT RESOLVED. THE ANALYZER WAS REPLACED WITH A DIFFERENT ONE, AND THE ISSUE WAS RESOLVED. THE ANALYZER WAS RETURNED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260784 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 229047

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER