BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3862133 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06844
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PATIENT¿S CLINICAL VISIT, IT WAS FOUND THERE WAS HIGH THRESHOLD AND NO CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. RADIOGRAPHIC CHECK CONFIRMED MYOCARDIUM PERFORATION. THE PHYSICIAN PLANNED TO REPLACE THE LEAD AND CURRENTLY PATIENT IS USING AN EXTERNAL PACEMAKER. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PATIENT¿S CLINICAL VISIT, IT WAS FOUND THERE WAS HIGH THRESHOLD AND NO CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. RADIOGRAPHIC CHECK CONFIRMED MYOCARDIUM PERFORATION. THE PHYSICIAN PLANNED TO REPLACE THE LEAD AND CURRENTLY PATIENT IS USING AN EXTERNAL PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339763 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R