BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3160282 · Received June 10, 2013

    Report

    Report Number
    2182208-2013-01820
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. (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 AFTER INSTALLING THE ANALYZER UPDATE, THE ANALYZER PRESENTED SOFTWARE PROBLEMS. AN ANALYZER SESSION COULD BE STARTED, BUT AFTER A WHILE, THE FOLLOWING ERROR MESSAGE WAS RECEIVED; "THE CONNECTION BETWEEN THE ANALYZER AND THE PROGRAMMER HAS BEEN LOST." IF THE SR RESET THE SESSION, IT IS SOLVED BUT AFTER A CERTAIN TIME THE ERROR MESSAGE IS SHOWN AGAIN. THE ANALYZER HAS BEEN RETURNED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260706 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 229047

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER