BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2964937 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02144
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 7, 2012
    Report Date
    January 30, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    (B)(4).

    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 FURTHER REPORTED THAT THERE WAS A CARDIAC PERFORATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN AND A MODERATE-SIZED PERICARDIAL EFFUSION WAS FOUND. A PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE EFFUSION. DEVICE INTERROGATION SHOWED CHANGES IN ATRIAL AND VENTRICULAR LEAD PARAMETERS REQUIRING REVISION. THE RIGHT ATRIAL (RA) LEAD WAS REVISED AND REMAINS IN USE. THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED, WAS REPOSITIONED, AND 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
    66771 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| L| R (B)(4) IMPLANTABLE CARDIAC DEFIBRILLATOR