BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2964543 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02044
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 14, 2012
    Report Date
    March 6, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. THE PRIMARY ANALYSIS FINDING NOTED NO ANOMALIES WERE FOUND. THE DISTAL ELECTRODE WAS COVERED WITH BODY TISSUE/FIBROTIC GROWTH AND WAS COVERED WITH BLOOD. VISUAL ANALYSIS NOTED THE LEAD HAD APPARENT EXPLANT DAMAGE.

    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 THE RIGHT ATRIAL (RA) LEAD PULLED BACK MONTHS AFTER IMPLANT. THE LEAD WAS DAMAGED DURING EXPLANT. THE LEAD WAS REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS THE RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66656 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR