BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELLENCE+

    MDR report key: 1990963 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02202
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. (B)(4). EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT IMPEDANCES HAVE BEEN CHRONICALLY BELOW 200 OHMS SINCE (B)(4) 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD'S UNIPOLAR AND BIPOLAR IMPEDANCE WERE BELOW 200 OHMS. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD'S UNIPOLAR AND BIPOLAR IMPEDANCE WERE BELOW 200 OHMS. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELLENCE+ IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. IMD49B ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other IMU49JB IMPLANTABLE PACING LEAD| IMU49JB IMPLANTABLE PACING LEAD| P1501DR IMPLANTABLE PULSE GENERATOR| P1501DR IMPLANTABLE PULSE GENERATOR