BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2787856 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-13831
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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 LEAD WAS NOT RECEIVED FOR EVALUATION. LOW RESISTANCE/IMPEDANCE OCCURRED. TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2009 21:00:14 AND (B)(6) 2009 09:00:12. PROGRAMMER S2D DATA FILE (B)(4) SHOWS TWO ALERT EVENTS FOR "A. PACING LEAD IMPEDANCE 171 OHMS" ON (B)(6) 2009 21:00:14 AND (B)(6) 2009 09:00:12. (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION AND THE DEVICE MET EXPECTED LONGEVITY. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY DEPLETION IS INDICATED. TIME OF RECOMMENDED REPLACEMENT TIME (RRT) IN SAVE TO DISK IS ON (B)(6) 2012 WITH DEVICE RRT<=2.6251 VOLT. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT=2.626 TO 2.622 VOLTS BETWEEN (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD IMPEDANCE HAS DECREASED SINCE IMPLANT AND A LEAD WARNING TRIGGERED FOR LOW IMPEDANCE. THE IMPEDANCE TREND HAS BEEN STABLE AND THE PHYSICIAN LEFT THE RA LEAD IN USE. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD THRESHOLD HAD SLOWLY INCREASED SINCE IMPLANT. THE PACE/SENSE PORTION OF THE RV LEAD WAS CAPPED AND A CHRONIC RV LEAD WAS USED INSTEAD. THE HIGH VOLTAGE THERAPY PORTION OF THE RV LEAD REMAINS STILL IN USE. IT WAS ALSO REPORTED THAT THE DEVICE HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) DUE TO EARLY BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD| 4068 IMPLANTABLE PACING LEAD