BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2131766 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-01020
    Event Type
    Malfunction
    Date Received
    June 16, 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
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4): NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A TELEMETRY FAILURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A TELEMETRY FAILLURE. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE 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