BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2953777 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01268
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 11, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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) IMPLANTABLE PULSE GENERATOR 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF THE TWO LEADS THE PATIENT HAD A PERICARDIAL EFFUSION. ECHOCARDIOGRAM AND COMPUTERIZED TOMOGRAPHY (CT) SCAN DID NOT SHOW EITHER LEAD BEING EXTRACARDIAC. IF THERE WAS A CARDIAC PERFORATION IT IS UNCLEAR WHICH LEAD MAY HAVE BEEN INVOLVED. THE FLUID WAS DRAINED FROM THE PERICARDIUM AND THE LEADS 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
    55395 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD