BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4830797 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-01727
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 26, 2015
    Report Date
    March 26, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 DID NOT CONFIRM THE REPORTED EVENT. HOWEVER IT WAS NOTED THAT THE PLASTIC ANTI-SLIP LAYER WAS RIPPED OFF OF THE LABEL OF THE PROGRAMMER HEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DOES NOT WORK FROM TIME TO TIME. THE RADIOFREQUENCY (RF) HEAD WAS RETURNED TO THE MANUFACTURER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378135 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER