BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2955338 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01421
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    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. 5086 IMPLANTABLE PACING LEAD 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS AFTER IMPLANT, THE PERICARDIAL EFFUSION WAS NOTED AND CARDIOMEGALY WAS OBSERVED AS BOTH THE ATRIAL AND VENTRICULAR LEAD WERE SUSPECTED TO HAVE PERFORATED. X-RAY INDICATED THAT THE LEAD MOVED SLIGHTLY BUT ECHOCARDIOGRAM INDICATED NO PERFORATION. THE PERICARDIAL EFFUSION IMPROVED AND THE PATIENT WAS DISCHARGED. THE LEADS ARE STILL 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
    59134 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| L| R (B)(4) IMPLANTABLE PULSE GENERATOR