BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152515 · Received June 7, 2013

    Report

    Report Number
    3008973940-2013-00082
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. A 6947M62 IMPLANTABLE TACHY LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A FEW WEEKS OF IMPLANT, PERICARDIAL EFFUSION WAS CONFIRMED. THE LEAD TIP WAS THOUGHT TO HAVE SLIGHTLY PERFORATED THE VENTRICLE. LATER, A THORACOTOMY CONFIRMED THAT THE PERICARDIAL FLUID WAS SERUM, AND APPROXIMATELY 450 ML WAS COLLECTED. IT WAS ALSO CONFIRMED THAT IT WAS NOT THE VENTRICULAR LEAD BUT THE ATRIAL LEAD WHICH HAD PERFORATED THE PERICARDIUM. THE CARDIAC MUSCLE AROUND THE PERFORATION SITE WAS SUTURED AND THE ATRIAL LEAD 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
    253139 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR Hospitalization| L| R D354DRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR