BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3153453 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06013
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AT THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED TO HAVE CAUSED A PERFORATION AFTER THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. THIS NECESSITATED A PERICARDIAL WINDOW TO EVACUATE THE EFFUSION. SUBSEQUENTLY, DURING THIS PROCEDURE, THE PHYSICIAN PERFORMED A MEDIAL STERNOTOMY TO PROVIDE BETTER VISIBILITY AND ACCESS. THE 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
    257180 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| L| R