BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI

    MDR report key: 3153474 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06038
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    January 29, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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. CONCOMITANT PRODUCTS: 5086MRI52 IMPLANTABLE PACING LEAD (B)(6) 2013; RVDR01 IMPLANTABLE PULSE GENERATOR (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION FROM AN UNKNOWN SOURCE. THE PATIENT WAS HOSPITALIZED FOR ANTIBIOTIC THERAPY. THE DEVICE AND TWO LEADS WERE EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257190 CAPSUREFIX MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R