BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2951907 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00303
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. CONCOMITANTS CONTINUE: 5086MRI IMPLANTABLE PACING LEAD: (B)(6) 2012.. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT A MONTH AFTER IMPLANT, THE PATIENT COMPLAINED OF CHEST PAIN AND VISITED A MEDICAL INSTITUTION. A VENTRICULAR CARDIAC PERFORATION WAS SUSPECTED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. ECHOCARDIOGRAPHY OR A COMPUTED TOMOGRAPHY SCAN CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIAL DRAINAGE WAS PERFORMED AND EGESTION OF FLUID WAS CONFIRMED. THE VENTRICULAR 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
    56764 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R A3DR01 IMPLANTABLE PACEMAKER