BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4161574 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11485
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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

    EVALUATION SUMMARY: ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND, HOWEVER THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT OF THE LV (LEFT VENTRICULAR) LEAD, THE PATIENT HAD A BIG POSTERIO/LATERAL VEIN WITH A HAZY SECTION IN THE MID-SECTION OF THE BRANCH. AFTER MUCH WORK IN THE BRANCH (BALLOONING, SUCTIONING CLOT), THE FOURTH POLE OF THE LV LEAD WAS STILL LOCATED IN THE MAIN CS (CORONARY SINUS). THE LEAD WAS NOT USED AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. DURING IMPLANT ATTEMPT OF THE ATRIAL LEAD, THE PATIENT WAS NOTED TO HAVE A LARGE RIGHT ATRIUM. AFTER MANY ATTEMPTS TO ATTAIN ADEQUATE P-WAVES, THE PHYSICIAN OPTED TO GO WITH ANOTHER LEAD MODEL PLACED IN A NEW LOCATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642030 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR