BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2954915 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01345
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 15, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MORNING AFTER THE IMPLANT, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION. THE SYSTEM WAS TESTED, AND ALL PARAMETERS APPEARED TO BE WITHIN NORMAL LIMITS. HOWEVER, A PERFORATION WAS SUSPECTED, AND AS A RESULT, THE ATRIAL AND VENTRICULAR LEADS WERE BOTH REPOSITIONED, IN ADDITION TO THE EFFUSION BEING DRAINED. THE LEADS BOTH 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
    59102 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER