BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2791017 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15392
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DAYS POST SYSTEM IMPLANT, THE RIGHT VENTRICULAR [RV] LEAD THRESHOLD MEASUREMENTS WERE HIGH. ADDITIONALLY, THE DEVICE HAD BEEN PROGRAMMED AT HIGH OUTPUT AT IMPLANT. IT WAS ALSO REPORTED THAT ON SUBSEQUENT MEASUREMENTS, THE RV LEAD THRESHOLD VARIED BETWEEN 1 AND 1.5 MV AND AGAIN MEASURED HIGH AT A RECENT SYSTEM CHECK. THE DEVICE WAS EXPLANTED AND REPLACED AS IT WAS NEAR THE ELECTIVE REPLACEMENT INDICATOR [ERI]; THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS MRI IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 5086MRI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R