BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2964858 · Received February 15, 2013

    Report

    Report Number
    3008973940-2013-00021
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT: 5086MRI45, (B)(6) 2012. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ELEVEN DAYS AFTER LEAD IMPLANTATION, THE PATIENT CAME TO HOSPITAL CLAIMING FATIGUE, ILL-FEELING, AND HAD REDUCED URINATION FREQUENCY. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED PERICARDIAL EFFUSION. THE SALES REPRESENTATIVE WAS CONTACTED BY THE PHYSICIAN TO CONDUCT A DEVICE CHECK BECAUSE THE PATIENT WAS IN SHOCK DUE TO CARDIAC TAMPONADE. LEAD IMPEDANCE WAS SLIGHTLY REDUCED, BUT THERE WAS NO CHANGE IN OTHER DATA. THE PERICARDIAL FLUID WAS DRAINED. OF NOTE, THE PATIENT STAYED HOSPITALIZED FOR REDUCED LIVER FUNCTION AND RENAL FUNCTION ALONG WITH PROGRESSION OF HEART FAILURE. A WEEK LATER, THE DEVICE WAS CHECKED AND INDICATED NO CHANGE IN DATA, AND THE PATIENT'S CONDITION IMPROVED WITH NO FURTHER PERICARDIAL EFFUSION. THE PATIENT WAS SCHEDULED FOR DISCHARGE A COUPLE OF DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69249 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC SINGAPORE OPERATIONS 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R A3DR01 IMPLANTABLE PULSE GENERATOR