BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3160431 · Received June 10, 2013

    Report

    Report Number
    2182208-2013-01825
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 25, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    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: THE PROGRAMMER WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMPLAINT THAT THE PRINTER WAS NOT WORKING CONSISTENTLY AND IT WAS ATTRIBUTED TO A MISSING GEAR ON THE PRINTER DRAWER, THEREFORE THE PRINTER DRAWER WAS REPLACED. ANALYSIS ALSO FOUND A NOISY SYSTEM FAN WHICH WAS REPLACED, AND A LOOSE ELECTROCARDIOGRAM (ECG) CONNECTOR ON THE LINK ELECTRONIC MODULE (LEM) BOARD, AND THE BOARD WAS REPLACED. CONCOMITANT PRODUCTS: PRODUCT ID 2067 RADIO FREQUENCY PROGRAMMER HEAD; PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER'S PRINTER WAS NOT WORKING. IT WAS FURTHER REPORTED THAT THE RADIO FREQUENCY PROGRAMMER HEAD WAS NOT WORKING. THE PROGRAMMER AND THE PROGRAMMER HEAD WERE RETURNED FOR SERVICE, AND THE PROGRAMMER SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260536 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090AM

    Patients

    Seq Age Sex Outcome Treatment
    1