BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4830070 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-01815
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Report Date
    March 4, 2015
    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: DURING ANALYSIS THE CUSTOMER COMMENTS OF A BROKEN HANDLE AND LATCH TABS BEING BROKEN OFF OF THE POWER CORD BAY DOOR WERE CONFIRMED. IT WAS ADDITIONALLY NOTED THAT THE KEYBOARD LATCH WAS BROKEN, THE SYSTEM FAN WAS NOISY AND THAT THERE WAS INTERNAL CORROSION PRESENT. DUE TO THE INTERNAL CORROSION THE DEVICE WAS DEEMED BEYOND ECONOMICAL REPAIR AND WAS TO BE SCRAPPED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER'S HANDLE AND BACK NEEDED REPAIR. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROGRAMMER SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378237 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 2067L RADIOFREQUENCY PROGRAMMER HEAD