BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4163190 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12433
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY- THE FULL LEAD WAS RETURNED IN SEGMENTS. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 4296-88 LEAD, (B)(6) 2012; 5076-52 LEAD, (B)(6) 2012; 6947M62 LEAD, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CHRONIC RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLD. RETRACTING THE HELIX ON THE RA LEAD WAS ATTEMPTED, BUT WITH NO SUCCESS DESPITE THE LEAD DISLODGING WITHIN THE ATRIUM. MANUAL TRACTION WAS APPLIED AND IT WAS REMOVED. MULTIPLE ATTEMPTS WERE MADE TO PLACE A NEW RA LEAD HOWEVER, THERE WAS GREAT DIFFICULTY GETTING MECHANICAL ATTACHMENT AND ACCEPTABLE ELECTRICAL VALUES. IT WAS NOTED THERE MAY HAVE BEEN A HELIX MALFUNCTION. AFTER APPROXIMATELY AN HOUR, THE DECISION WAS MADE TO REMOVE THE RA LEAD. A DIFFERENT RA LEAD WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE CHRONIC LEFT VENTRICULAR (LV) LEAD SHOWED NO CAPTURE. THE LV LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643776 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR D334TRM ICD