BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4162338 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12820
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 4, 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, ANALYZED, AND NO ANOMALIES WERE FOUND. HOWEVER, IT WAS NOTED THAT THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE HELIX WOULD NOT DEPLOY. IT WAS NOTED THAT THE PHYSICIAN PERFORMED THIRTY ROTATIONS WITH THE ROTATION TOOL AND THE HELIX WOULD NOT DEPLOY. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640686 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 00071 YR