BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991244 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08224
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYSIS SHOWS ATRIAL OVERSENSING DUE TO FFRW (FAR-FIELD R-WAVES). FFRW OVERSENSING WAS NOTED ON THE SAVED ELECTROGRAM STRIPS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRESENTED IN THE EMERGENCY ROOM WITH SYNCOPE DUE TO OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD. THE PATIENT IS NOTED TO BE 100% ATRIAL PACED. SYSTEM EVALUATION SHOWS NOISE ON THE RA LEAD THAT COINCIDED WITH ARM MOVEMENT RESULTING IN INHIBITION OF ATRIAL PACING AND OCCASIONAL DROPPED QRS BEATS. MODERATE FARFIELD WAS NOTED ON THE RA LEAD ELECTROGRAMS. ATTEMPTED REPROGRAMMING OF THE LEAD PARAMETERS WAS UNABLE TO RESOLVE THE OVERSENSING. THE PATIENT IS TRANSFERRED TO A LARGER HOSPITAL AND IS CONSIDERED FOR AN ATRIAL LEAD REVISION. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468124 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| L| R ADDR01 IPG, 5076-52 LEAD