BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991756 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-07972
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THAT IMPEDANCE ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. AN OUT OF TOLERANCE (OOT) SUB THRESHOLD LEAD IMPEDANCE ALERT OCCURRED ON 2014-04-25. MAXIMUM LEFT VENTRICLE PACE IMPEDANCE ROSE FROM 532 OHMS THE WEEK ENDING 2014-04-23 TO GREATER THAN 4000 OHMS THE WEEK ENDING 2014-04-30.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 4193-78, LEAD, IMPLANTED: (B)(6) 2004; D314TRG, ICD, IMPLANTED: (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE ALERTED DUE TO HIGH ATRIAL LEAD IMPEDANCE. ALSO INDICATED WERE SHORT ATRIAL ACTIVATION (A-A) INTERVALS, INAPPROPRIATE MODE SWITCHING, AND NO CAPTURE AT MAXIMUM OUTPUT. A LEAD FRACTURE WAS SUSPECTED. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD WAS TURNED OFF DUE TO PATIENT MEDICAL ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468641 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R 6945-65