BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2953735 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01307
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 17, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR LESS THAN SIX MONTHS AFTER IMPLANT. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR LEAD HAD SUSPECTED INSULATION DAMAGE AS THE LEAD HAD LOW BIPOLAR IMPEDANCE, HIGH THRESHOLD, AND UNDERSENSING WITH SMALL R-WAVES. THE DEVICE WAS EXPLANTED AND THE LEAD REMAINS IN USE PROGRAMMED TO UNIPOLAR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57391 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R (B)(4) IMPLANTABLE BI-VENTRICULAR PULSE GENERATOR