BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4160219 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11989
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. PRODUCT EVENT SUMMARY: ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    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. CONCOMITANT MEDICAL PRODUCTS: ICD D354TRG, IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN SYNCOPE. IN ADDITION, IT WAS REPORTED THAT THE PATIENT HAD ENCOUNTERED AN EPISODE OF ASYSTOLE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND INTERMITTENT THRESHOLDS, LOSS OF CAPTURE AND A SUSPECTED DISLODGEMENT. THE RV LEAD WAS CAPPED AND REPLACED. THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED REPLACED FOR NO PACING THAT WAS EXPECTED DUE TO THE RV LEAD ISSUES. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637781 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| L| R