BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYNC III

    MDR report key: 1854850 · Received October 5, 2010

    Report

    Report Number
    6000094-2010-01767
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 10, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P010015/S005
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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) THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE CRT DEVICE SHOWS THAT MINIMUM IMPEDANCE VALUES OF 24 OHMS WERE RECORDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE ON THE LEFT VENTRICULAR (LV) AND RIGHT VENTRICULAR (RV) LEADS SHOWED LOW MINIMUM VALUES. A LEAD WARNING ON THE ATRIAL LEAD WAS ALSO NOTED. THE PATIENT IS IN ATRIAL FIBRILLATION. ENGINEERING THOUGHT THAT THE IMPEDANCE VALUES WERE NOT REAL AND MAY BE DUE TO THE FACT THAT THE PATIENT IS IN AF WITH A FAST VENTRICULAR RESPONSE AND ALMOST ALWAYS SENSING. THE SYSTEM REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC III ASKU DXY MEDTRONIC S.A. 8042 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other