BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3051035 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04768
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    July 9, 2012
    Report Date
    February 4, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: A3DR01 IMPLANTABLE PULSE GENERATOR: (B)(6) 2012. 5086MRI IMPLANTABLE PACING: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST IMPLANT, THE PATIENT WAS SEEN FOR AN OFFICE VISIT AND THE PATIENT WOUND WAS NOTED TO HAVE REDNESS AND PUS AT THE LEFT BORDER OF THE INCISION. CULTURE OF THE PURULENT MATTER IDENTIFIED STAPHYLOCOCCUS. THE PATIENT WAS GIVEN ANTIBIOTICS. THE PACING SYSTEM REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE SURESCAN POST APPROVAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153349 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention