BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 4161361 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11555
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 19, 2013
    Report Date
    July 22, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 LEAD THRESHOLDS INCREASED FROM 2.5 VOLTS AT 0.6 MILLISECONDS TO 3.5 VOLTS AT 0.6 MILLISECONDS. THE R WAVES WERE SMALL BUT STABLE AT 3.4 MILLIVOLTS. THE LEAD WAS ELECTIVELY REPLACED AT THE TIME OF GENERATOR REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642262 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R P1501DR IMPLANTABLE PULSE GENERATOR