BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3862193 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01378
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 17, 2014
    Report Date
    March 30, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: A 5086MRI58 LEAD IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH WEAKNESS, POSITIVE BLOOD CULTURES, ENDOCARDITIS, AND VEGETATION WAS NOTED ON THE LEADS. THE RIGHT VENTRICULAR (RV) LEAD WAS ALSO REPORTED TO HAVE DIMINISHED R WAVES. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND THE ENTIRE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED. THE PATIENT WAS ENROLLED IN (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338024 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 5086MRI52 LEAD