BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151932 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01217
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 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 COMMENT THAT IT BOOTED TO AN ERROR. THE HARD DRIVE WAS RECONFIGURED AND THE SOFTWARE RELOADED. ANALYSIS ALSO FOUND A LOOSE ELECTROCARDIOGRAM (ECG) CONNECTOR SO THE LINK ELECTRONICS MODULE (LEM) BOARD WAS REPLACED AND CALIBRATED, A NOISY SYSTEM FAN WHICH WAS REPLACED AND BROKEN TABS ON THE POWER CORD BAY DOOR, SO THE POWER CORD BAY WAS REPLACED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 2067L PROGRAMMER RF (RADIO-FREQUENCY) HEAD, 2290 PACING SYSTEM ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO TURN ON THE PROGRAMMER FOR A CASE, WHEN A BLACK SCREEN WITH AN ERROR MESSAGE WAS DISPLAYED. SEVERAL MORE ATTEMPTS WERE MADE, WITH THE SAME RESULT. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO TURN ON THE PROGRAMMER FOR A CASE, WHEN A BLACK SCREEN WITH AN ERROR MESSAGE WAS DISPLAYED. SEVERAL MORE ATTEMPTS WERE MADE, WITH THE SAME RESULT. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253272 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1