BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2955302 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-00814
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 26, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. CONCOMITANT PRODUCT: 6944 IMPLANTABLE DEFIBRILLATION LEAD (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED SEVERAL SHOCKS AND WAS SEEN IN THE EMERGENCY ROOM. THE DEVICE WAS REPLACED DUE TO ELECTIVE REPLACEMENT INDICATOR. NOISE AND OVERSENSING WAS SEEN ON BOTH LEADS. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED. THE ATRIAL LEAD COULD NOT BE EXTRACTED AND IS STILL 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
    59073 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| L| R D154ATG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR