BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3746579 · Received April 11, 2014

    Report

    Report Number
    9614453-2014-00898
    Event Type
    Death
    Date Received
    April 11, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 14, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. CONCOMITANT MEDICAL PRODUCTS: 5086MRI52 LEAD IMPLANTED: 2013-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED AND DIED APPROXIMATELY THREE MONTHS POST IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. THE PATIENT IS REPORTED TO HAVE HAD AN AORTIC VALVE REPLACEMENT PROCEDURE WHICH LED TO COMPLETE ATRIAL/VENTRICULAR BLOCK AND DEVICE SYSTEM IMPLANT ONE WEEK POST VALVE SURGERY. THE PATIENT HAD SUSPECTED ENDOCARDITIS AND VEGETATION WAS NOTED ON THE RIGHT ATRIAL LEAD. THE DEVICE SYSTEM WAS EXPLANTED; THE PATIENT WAS STARTED ON ANTIBIOTIC THERAPY AND IS REPORTED TO HAVE DIED THE DAY AFTER SYSTEM REMOVAL. THE CAUSE AND CIRCUMSTANCES OF THE PATIENT DEATH HAVE BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220381 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Death| H| R 5086MRI58 LEAD