BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152429 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01560
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. CONCOMITANT PRODUCT: PRODUCT ID: 2067, RADIO FREQUENCY PROGRAMMER HEAD. (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 THAT THERE WAS "TELEMETRY FAILURE" WITH THE PROGRAMMER. BOTH THE PROGRAMMER AND THE PROGRAMMER HEAD WERE RETURNED FOR SERVICE. IT WAS FURTHER REQUESTED THAT THE PROGRAMMER BE CALIBRATED/EVALUATED AND RECEIVE UPGRADED PARTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS "TELEMETRY FAILURE" WITH THE PROGRAMMER. BOTH THE PROGRAMMER AND THE PROGRAMMER HEAD WERE RETURNED FOR SERVICE. IT WAS FURTHER REQUESTED THAT THE PROGRAMMER BE CALIBRATED/EVALUATED AND RECEIVE UPGRADED PARTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253104 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1