BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2131686 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00914
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 27, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    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 COULD NOT CONFIRM THE ALLEGATION; HOWEVER, IT WAS CONCLUDED THAT THE POWER CORD DOOR WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A SYSTEM ERROR AT BOOT UP. THE MEDTRONIC REPRESENTATIVE WAS CALLED TO RUN THE SERVICE DISK TO CORRECT THE SOFTWARE. THE PROGRAMMER WAS LATER RETURNED FOR SERVICE DUE TO THE ERROR MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER ENCOUNTERED A SYSTEM ERROR. THE MEDTRONIC REPRESENTATIVE WAS CALLED TO RUN THE SERVICE CORRECT SOFTWARE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A SYSTEM ERROR AT BOOT UP. THE MEDTRONIC REPRESENTATIVE WAS CALLED TO RUN THE SERVICE DISK TO CORRECT THE SOFTWARE. THE PROGRAMMER WAS LATER RETURNED FOR SERVICE DUE TO THE ERROR MESSAGE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT THE PROGRAMMER ENCOUNTERED A SYSTEM ERROR. THE MEDTRONIC REPRESENTATIVE WAS CALLED TO RUN THE SERVICE CORRECT SOFTWARE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAM W/TELEMETRY C PROGRAMMER DXY MEDTRONIC, INC. 2090W ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2067 PROGRAMMER RF HEAD| 2067 PROGRAMMER RF HEAD