BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 2865757 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17902
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    October 23, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. (B)(4) IMPLANTABLE PULSE GENERATOR 2011 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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. ATRIAL PACING IMPEDANCE, 13,000 HIGH IMPEDANCE PACES IN LAST 439 DAYS (SINCE ATRIAL LEAD WARNING). THE ANALYST COMMENTED ATRIAL LEAD WARNING ON (B)(6) 2011, 439 DAYS BEFORE THIS FILE WAS SAVED. 13,737 HIGH IMPEDANCE ATRIAL PACES (30/DAY) AND 175 ATRIAL SHORT INTERVALS. NO HIGH RATE OR MODE SWITCH EPISODES. IMPEDANCE, SENSING, AND THRESHOLDS ARE ALL STABLE OVER LAST 60 WEEKS. IT WAS ALSO NOTED THAT THERE WERE 175 ATRIAL SHORT INTERVALS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATRIAL LEAD WARNING WAS TRIGGERED FOR HIGH IMPEDANCES. 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 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR 5076 IMPLANTABLE PACING LEAD