BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3153483 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01442
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    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

    PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE DEVICE POWERED UP WITH AN ERROR. AS A RESULT, SOFTWARE WAS RELOADED. IT WAS ALSO NOTED THAT THE SYSTEM FAN WAS NOISY.

    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: PRODUCT ID 2067L PROGRAMMER RF (RADIO-FREQUENCY) HEAD; 2290 PACING SYSTEM ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED A FATAL ERROR WHEN POWERED ON. THE SERVICE DISKETTE WAS ATTEMPTED BUT DID NOT CLEAR THE ERROR. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257369 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1