BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990839 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08459
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH, AND BLOOD. IT WAS ALSO NOTED THE LEAD WAS RECEIVED WITH DRIED TISSUE/BODY FLUID ON HELIX.

    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 THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN ATTEMPTED TO PLACE THE ATRIAL LEAD BUT AFTER SEVERAL REPOSITIONING ATTEMPTS THE SCREW OF THE LEAD APPEARED TO BECOME STICKY AND WOULD NOT DEPLOY SMOOTHLY. IT WAS NOTED THAT THE SCREW JUMPED OUT ALL AT ONCE AND WOULD NOT DEPLOY SLOWLY. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED INSTEAD. ADDITIONALLY, IT WAS REPORTED WHEN THE PHYSICIAN WAS ATTEMPTING TO PLACE THE RIGHT VENTRICULAR (RV) LEAD THE LEAD HAD HIGH THRESHOLDS IN SEVERAL LOCATIONS. THE PHYSICIAN FELT THERE WAS AN ISSUE WITH THE SCREW DUE TO TISSUE BEING STUCK WHEN THE SCREW WAS RETRACTED. IT WAS ALSO NOTED THAT THE PHYSICIAN FELT THAT A LONGER RV LEAD WAS NEEDED FOR THIS PATIENT. THE LEAD WAS REMOVED AND A LONGER LEAD INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470149 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR