BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2207081 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01869
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 20, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): ANALYSIS CONFIRMED THAT THE PROGRAMMER BOOTED UP TO A VITATRON SCREEN. IT WAS ALSO NOTED THAT THE COOLING 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THAT THE PROGRAMMER BOOTED UP TO A VITATRON SCREEN. IT WAS ALSO NOTED THAT THE COOLING FAN WAS NOISY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VITATRON SESSION, THE PROGRAMMER WAS UNPLUGGED. ONCE IT WAS POWERED BACK ON, IT WAS STUCK ON VITATRON AND COULD NOT BE SWITCHED BACK TO MEDTRONIC. ANOTHER PROGRAMMER WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. LATER, AN ERROR MESSAGE OCCURRED WHEN THE RUNNING THE SERVICE DISK IN AN ATTEMPT TO CORRECT THE ISSUE.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VITATRON SESSION, THE PROGRAMMER WAS UNPLUGGED. ONCE IT WAS POWERED BACK ON, IT WAS STUCK ON VITATRON AND COULD NOT BE SWITCHED BACK TO MEDTRONIC. ANOTHER PROGRAMMER WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. LATER, AN ERROR MESSAGE OCCURRED WHEN RUNNING THE SERVICE DISK IN AN ATTEMPT TO CORRECT THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R 2290 PACING SYSTEM ANALYZER| 2067L PROGRAMMER RF HEAD| 2067L PROGRAMMER RF HEAD| 2290 PACING SYSTEM ANALYZER| 2290 PACING SYSTEM ANALYZER| 2067L PROGRAMMER RF HEAD