BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2812352 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16673
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4) - EVALUATION SUMMARY: PERFORMANCE DATA WERE COLLECTED FROM THE DEVICE AND ANALYZED. THERE WERE THREE PATIENT ALERTS FOR LEAD FAILURE PREDICTOR BETWEEN(B)(4) 2012. THERE WERE EIGHT VENTRICULAR NONSUSTAINED TACHYCARDIA EPISODES LESS THAN OR EQUAL TO 210 MS BETWEEN (B)(4) 2012. THERE WERE FIVE LEAD FAILURE PREDICTOR HIGH RATE NONSUSTAINED EPISODES LESS THAN OR EQUAL TO 212 MS ON AVERAGE VENTRICULAR CYCLE BETWEEN (B)(4) 2012. THE VENTRICULAR SHORT INTERVAL COUNT WAS 103.3 COUNTS ON AVERAGE PER DAY IN 7.84 DAYS BETWEEN (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4): THE FULL LEAD IN SEGMENTS WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE OUTER INSULATION HAD COSMETIC METAL ION OXIDATION, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS CUT, THE OUTER INSULATION WAS MELTED, THE OUTER INSULATION WAS BREACHED/TORN, THE OUTER INSULATION WAS PULLED/STRETCHED/OVERSTRESS, AND THE LEAD HAD APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD ALERT TRIGGERED. OVERSENSING WAS NOTED IN THE ATRIAL AND VENTRICULAR ELECTROGRAMS (EGM). ONE EPISODE OF ATRIAL OVERSENSING WAS ELECTRICAL MAGNETIC INTERFERENCE (EMI). IT WAS ALSO NOTED THE R WAVES WERE SMALL. POCKET MANIPULATION WAS LATER PERFORMED AND THERE WAS SOME NOISE IDENTIFIED IN THE ATRIAL CHANNEL, BUT IT WAS NOT POSSIBLE TO REPRODUCE ANYTHING IN THE VENTRICLE. THERE WERE SEVERAL STORED EPISODES ON THE VENTRICULAR EGM SHOWING NOISE, BUT NO EXTERNAL SOURCE OF NOISE COULD BE IDENTIFIED. THE LEADS REMAIN IN USE WITH A SYSTEM REVISION PLANNED FOR THE NEAR FUTURE TO EXTRACT BOTH LEADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD ALERT TRIGGERED. OVERSENSING WAS NOTED IN THE ATRIAL AND VENTRICULAR ELECTROGRAMS (EGM). ONE EPISODE OF ATRIAL OVERSENSING WAS ELECTRICAL MAGNETIC INTERFERENCE (EMI). IT WAS ALSO NOTED THE R WAVES WERE SMALL. POCKET MANIPULATION WAS LATER PERFORMED AND THERE WAS SOME NOISE IDENTIFIED IN THE ATRIAL CHANNEL, BUT IT WAS NOT POSSIBLE TO REPRODUCE ANYTHING IN THE VENTRICLE. THERE WERE SEVERAL STORED EPISODES ON THE VENTRICULAR EGM SHOWING NOISE, BUT NO EXTERNAL SOURCE OF NOISE COULD BE IDENTIFIED. THE LEADS REMAIN IN USE WITH A SYSTEM REVISION PLANNED FOR THE NEAR FUTURE TO EXTRACT BOTH LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D354DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB