BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3990138 · Received August 7, 2014

    Report

    Report Number
    2182208-2014-02263
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    April 29, 2014
    Report Date
    June 5, 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: ANALYSIS CONFIRMED THAT THE OVERLAY AND THE FOOT PAD WERE BROKEN. ANALYSIS ALSO FOUND THAT THE TABS ON THE POWER CORD BAY DOOR WERE BROKEN AND THAT THE UNIT WAS UNREPAIRABLE DUE TO INTERNAL CORROSION. THE PROGRAMMER WAS THEREFORE TO BE SCRAPPED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD A CRACKED SCREEN AND A BROKEN PAD ON THE BOTTOM OF ITS CASE. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE PROGRAMMER SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465022 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD