BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2953287 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01032
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD POSSIBLE PERICARDITIS IN ADDITION TO SOME PAIN. THE MATERIAL OF THE DEVICE AND LEADS WERE QUESTIONED. THE DEVICE AND LEADS REMAIN IN USE. NO COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56295 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR (B)(4) IMPLANTABLE PULSE GENERATOR