BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4160655 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11795
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD AND BODY TISSUE/FIBROTIC GROWTH. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT AND STRETCHING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO ADVANCE THE IMPLANTABLE PACING LEAD PAST A POINT BEFORE THE SUPERIOR VENA CAVA (SVC) DURING THE ATTEMPTED RIGHT ATRIAL (RA) IMPLANT PROCEDURE. WHEN THE LEAD WAS REMOVED AND EXAMINED, CARDIAC TISSUE WAS FOUND TO BE EMBEDDED IN THE LEAD HELIX WHICH COULD NOT BE COMPLETELY REMOVED. THE PHYSICIAN REQUESTED A NEW LEAD FOR COMPLETION OF THE IMPLANT PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641323 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR