BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991501 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02138
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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

    PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT OF THE PROGRAMMER SHUTTING DOWN, THE DEVICE RAN FOR 24 HOURS CONTINUOUSLY WITH NO ERROR. ANALYSIS DID FIND THAT THE SYSTEM FAN WAS NOISY AND IT WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER KEPT SHUTTING DOWN DURING FOLLOW-UP. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER KEPT SHUTTING DOWN DURING FOLLOW-UP. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470340 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 R2290 SOFTWARE ANALYZER| R2290 SOFTWARE ANALYZER