BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 5713797 · Received June 9, 2016

    Report

    Report Number
    2182208-2016-01601
    Event Type
    Malfunction
    Date Received
    June 9, 2016
    Date of Event
    February 22, 2016
    Report Date
    March 7, 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

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: AT ANALYSIS IT WAS NOTED THAT THE UPPER CASE LENS WAS CRACKED, THAT THE DEVICE WOULD NOT INTERROGATE AND FAILED ITS UPLINK TEST. WHEN THE CABLE WAS REPLACED WITH A KNOWN, GOOD CABLE THE DEVICE INTERROGATED AND PASSED FUNCTIONAL TESTING. THE DEVICE WAS TO BE SENT ON FOR REPAIR AND RESTOCK. (B)(4).

    Description of Event or Problem · 1

    THE RADIOFREQUENCY PROGRAMMER HEAD ORIGINALLY RETURNED WITH NO INFORMATION SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTU RER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365991 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067

    Patients

    Seq Age Sex Outcome Treatment
    1