BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    MDR report key: 3152659 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06704
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. CONCOMITANT PRODUCTS: A3DR01 IMPLANTABLE PACEMAKER (B)(6) 2013; 5086MRI IMPLANTABLE PACING LEAD 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICLE (RV) AND RIGHT ATRIAL (RA) LEADS WERE SUSPECTED OF A CARDIAC PERFORATION. IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED DUE TO COMPLAINT OF FATIGUE AND INCREASED PERICARDIAL FLUID WAS CONFIRMED. THE PATIENT WAS ADMITTED AND DRAINAGE WAS PERFORMED. THE RV AND RA 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
    252259 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| L| R