BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3860241 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01508
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 28, 2014
    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 MANUFACTURER'S ANALYSIS IT WAS DETERMINED THAT THERE WAS A TEAR IN THE INSULATION OF THE CABLE, THAT THERE WAS A CRACKED LIGHT-EMITTING DIODE WINDOW AND THAT THE LABEL WAS DELAMINATED. ALL WERE REPLACED TO RESOLVE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WHICH WAS ORIGINALLY RETURNED BECAUSE WATER HAD BEEN ACCIDENTALLY DROPPED ON IT SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE RADIOFREQUENCY PROGRAMMER HEAD ORIGINALLY RETURNED AS AN ASSOCIATED DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342326 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER