BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4162442 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12763
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 8, 2014
    Report Date
    August 12, 2014
    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

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE HELIX OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED PHRENIC NERVE/DIAPHRAGMATIC STIMULATION AND THE ATRIAL LEAD WAS NOT SENSING IN THE ATRIUM. THE LEAD WAS REPOSITIONED. A FEW WEEKS AFTER THE LEAD WAS REPOSITIONED THE LEAD DEMONSTRATED HIGH THRESHOLD MEASUREMENTS DUE TO DISLODGEMENT. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639699 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R A2DR01 IPG, 5086MRI-52 LEAD