BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152312 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06864
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. CONCOMITANT PRODUCTS: 407658 IMPLANTABLE PACING LEAD - (B)(6) 2013; ADDR01 IMPLANTABLE PULSE GENERATOR - (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE HALF HOUR POST IMPLANT IN THE HOLDING AREA THE PATIENT DEVELOPED MID STERNAL CHEST PAIN. THE LEADS WERE CHECKED AND ALL WERE NORMAL TO EXCELLENT. A STAT CHEST X-RAY AND ECHO WERE ORDERED. THE EP DETERMINED THAT THERE WAS EVIDENCE ON ECHO OF POSSIBLE SMALL EFFUSION WHICH COULD NOT BE DETERMINED IF IT WAS PRE-EXISTING OR NEW. THE PATIENT WAS BROUGHT BACK INTO THE LAB AND BOTH LEADS, ATRIAL AND RIGHT VENTRICULAR, WERE REPOSITIONED FOR SAFETY OF THE PATIENT. THE PATIENT¿S PAIN SEEMED TO SUBSIDE AND THE LEADS REMAIN 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
    252639 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| L| R