BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4162588 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12706
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY- THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN PLACED THE RIGHT VENTRICULAR (RV) LEAD WITHOUT ANY PROBLEMS. R WAVES AND THRESHOLDS WERE EXCELLENT. AS THE PHYSICIAN WAS SUTURING THE LEAD VALUES WERE CHECKED AGAIN AND IT WAS NOTICED THAT THE R WAVES WERE LESS THAN 1MV. THE PHYSICIAN REPOSITIONED THE LEAD AND THE LEAD SHOWED HIGH THRESHOLDS. NUMEROUS LOCATIONS WERE TRIED AND STILL THERE WERE HIGH THRESHOLDS. THE PHYSICIAN REMOVED THE FIRST LEAD AND TRIED A SECOND LEAD GETTING THE SAME RESULTS. UPON FURTHER EVALUATION IT WAS DETERMINED THE ANALYZER CABLE WAS DEFECTIVE AND RESPONSIBLE FOR ERRONEOUS NUMBERS ON THE VENTRICLE SIDE. THE LEAD WAS CHECKED ON THE ATRIAL CHANNEL AND NUMBERS WERE WITHIN NORMAL LIMITS. THE SECOND 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
    644279 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 00082 YR