BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2865059 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17647
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 28, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL END LOW VOLTAGE ELECTRODE WAS COVERED IN BLOOD AND BODY TISSUE/FIBROTIC GROWTH. THE LEAD ALSO HAD APPARENT IMPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD DEMONSTRATED HIGH IMPEDANCE MEASUREMENTS AND A HIGH THRESHOLD. IT WAS ALSO NOTED THAT NINE DIFFERENT LOCATIONS WERE ATTEMPTED. THE TISSUE WAS ALSO REMOVED FROM THE TIP OF THE LEAD. THE ANALYZER CABLE WAS CHANGED FIRST AND THEN A NEW LEAD WAS IMPLANTED. THE FIRST ATTEMPTED LEAD WAS NOT USED. 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 MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR