BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2952217 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00456
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 7, 2012
    Report Date
    January 24, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE ANALYST NOTED THAT THE LEAD WAS RETURNED WITH THE STYLET IN THE LEAD AND THE HELIX WAS PULLED/STRETCHED. IN ADDITION, BLOOD WAS VISIBLE ON THE ELECTRODES OF THE DISTAL END. THE ANALYST COMMENTED THAT THE LEAD DAMAGE OCCURRED DURING THE IMPLANT ATTEMPT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL PORTION OF THE ELECTRODE HAD BLOOD ON IT, THE HELIX WAS PULLED/STRETCHED DUE TO OVERSTRESS, AND THE LEAD APPEARED DAMAGE AT IMPLANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE HELIX OF THE ATRIAL LEAD STRETCHED WHEN IT BECAME CAUGHT ON THE END OF THE SHEATH. THE LEAD WAS REMOVED AND A DIFFERENT ATRIAL LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55829 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR