BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1922939 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13139
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. EVALUATION SUMMARY (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WERE TWO PATIENT ALERTS FOR OUT OF TOLERANCE LEAD IMPEDANCE ON (B)(6) 2010 AND (B)(6) 2010. THE ATRIAL PACE BIPOLAR IMPEDANCE WAS 4047 OHMS ON (B)(6) 2010, AND 3838 OHMS ON (B)(6) 2010. THE DAILY ATRIAL PACE BIPOLAR IMPEDANCE RANGE FROM 437 OHMS TO 4047 OHMS BETWEEN (B)(6) 2010 AND (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD IMPEDANCE RECORDED BY THE IMPLANTED DEVICE WAS >3000 OHMS ON (B)(6) 2010. FOLLOWUP REVEALED THAT THE LEAD IMPEDANCE HAS COME DOWN. THE LEAD 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 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other 6944 IMPLANTABLE TACHY LEAD| 6944 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB