BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2964855 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01953
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 17, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE CONDUCTOR WAS KINKED/BUCKLED, THE OUTER INSULATION WAS BREACH CUT, THERE WAS BLOOD ON THE CONDUCTOR (NOT OBSTRUCTED), THE DISTAL ELECTRODE WAS COVERED IN BLOOD, AND THE LEAD HAD APPARENT EXPLANT DAMAGE. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A FEVER, CHEST PAIN, A DECREASE IN BLOOD PRESSURE AND PERCARDIAL EFFUSION DUE TO A SUSPECTED CARDIAC PERFORATION. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD R WAVE MEASUREMENTS HAD DECREASED. RV LEAD REPOSITIONING WAS PLANNED; HOWEVER, DUE TO THE PATIENT'S FEVER, THE LEAD WAS REMOVED. THE LEAD WAS LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69254 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| L| R A5DR01 IMPLANTABLE PULSE GENERATOR