BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4831304 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-01670
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 19, 2015
    Report Date
    March 23, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 COULD NOT CONFIRM THE REPORTED EVENT. THE PROGRAMMER WAS ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO INTERROGATE AN IMPLANTABLE DEVICE WITH THE PROGRAMMER. THE PROGRAMMER WAS RETURNED FOR SERVICING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378480 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090FR

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY (RF) HEAD