BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 6005398 · Received October 6, 2016

    Report

    Report Number
    2182208-2016-02264
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    August 2, 2016
    Report Date
    August 19, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: IT COULD NOT BE CONFIRMED THAT THE RADIOFREQUENCY (RF) HEAD WAS NOT WORKING. THE RF HEAD FAILED AN INCOMING ELECTRICAL FIELD IMMUNITY TEST. THE RF HEAD WAS FOUND TO BE INTERNALLY CONTAMINATED, AS WAS THE LOWER CASE COATING. THE RF HEAD CABLE WAS DAMAGED, THE INSULATION WAS PUNCTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIOFREQUENCY (RF) HEAD WAS "NOT WORKING". THE RF HEAD HAS BEEN RETURNED TO SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE RADIOFREQUENCY PROGRAMMER HEAD SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660627 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067

    Patients

    Seq Age Sex Outcome Treatment
    1