BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3062213 · Received April 16, 2013

    Report

    Report Number
    2649622-2013-05100
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. (B)(4): RVDR01 IMPLANTABLE PULSE GENERATOR (IPG) 2012-(B)(6); 5086MRI IMPLANTABLE PACING LEAD 2012-(B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT, THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD, VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    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 THAT NOISE CAUSING INHIBITION WAS NOTED ON THE VENTRICULAR EPISODES. A RIGHT VENTRICULAR (RV) LEAD REVISION WAS STARTED. PRESSURE PLACED ON THE DEVICE RESULTED IN RV PACING INHIBITION. MANIPULATION OF THE DEVICE AND RV LEAD DID NOT PRODUCE ANY RESULTS, SO TO BE CAUTIOUS, THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE RV LEAD. UPON REMOVAL, A LARGE CUT IN THE RV LEAD WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162127 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R