BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2964662 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02149
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    February 11, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT EVENT SUMMARY: PERFORMANCE DATA WERE COLLECTED FROM THE DEVICE AND ANALYZED. THE WEEKLY PACE IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR MINIMUM AND MAXIMUM ATRIAL PACING IMPEDANCE FROM 1168 OHMS TO 6144 OHMS PEAK BETWEEN (B)(4) 2011 AND (B)(4) 2012. CONCOMITANT PRODUCT: (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 2007 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED SEVERAL INAPPROPRIATE SHOCKS DUE TO VENTRICULAR LEAD NOISE. THE RIGHT VENTRICULAR LEAD IMPEDANCE WAS HIGH. IT WAS ALSO REPORTED, THE ATRIAL LEAD HAD DEMONSTRATED A SUDDEN INCREASE IN LEAD IMPEDANCE LAST YEAR. THE PHYSICIAN ELECTED TO LEAVE THE ATRIAL LEAD IMPLANTED AND REPROGRAM THE DEVICE TO VENTRICULAR PACING AT THAT TIME. BOTH LEADS WERE CAPPED DURING THE RECENT SYSTEM REVISION AND THE VENTRICULAR LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66391 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5594

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization| L| R 6944 IMPLANTABLE TACHY LEAD