BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2131722 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10542
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERICARDIAL EFFUSION AFTER THE HEART WAS PERFORATED DURING THE IMPLANT OF THE RIGHT VENTRICULAR LEAD. IT WAS ALSO REPORTED THAT THE THRESHOLDS WERE HIGH ON INITIAL PLACEMENT OF THE LEAD AND AFTER THE SECOND PLACEMENT THE PATIENT'S BLOOD PRESSURE DROPPED AND PERICARDIAL EFFUSION AND RESTRICTED HEART MOTION WERE SEEN UNDER FLUORO. THE CASE WAS STOPPED AND THE PATIENT WAS SENT TO SURGERY FOR PERICENTESIS. THE LEAD REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS MRI IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 5086MRI ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR