BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4161526 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11502
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. CONCOMITANT MEDICAL PRODUCTS: 7120 LEAD, IMPLANTED (B)(6) 2010; D314TRG ICD, IMPLANTED (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD EARLY BATTERY DEPLETION DUE TO HIGH THRESHOLDS ON THE LEFT VENTRICULAR (LV) LEAD. LV CAPTURE WAS INTERMITTENT AT THE HIGHEST OUTPUT. THE DEVICE WAS EXPLANTED AND REPLACED. DURING THE DEVICE CHANGEOUT THE ORIGINAL INTENT WAS TO ATTEMPT TO REMOVE OR REPOSITION THE LV LEAD OR ADD AN ADDITIONAL LV LEAD. THE PATIENT¿S ANATOMY WOULD NOT ALLOW FOR ADDITIONAL LEADS TO BE PLACED BECAUSE THE SUBCLAVIAN WAS OCCLUDED. EXTRACTION WAS ABANDONED BECAUSE THE LEAD GOT HUNG UP IN THE SUPERIOR VENA CAVA (SVC). BECAUSE THE PATIENT WAS DEPENDENT, THE LV PORT WAS PLUGGED AND THE PATIENT WAS BROUGHT BACK AT A LATER TIME TO EXTRACT THE LEAD AND ADDED A NEW LV LEAD. DURING THE SUBSEQUENT PROCEDURE TO EXTRACT THE LEAD, THE LEAD BROKE IN HALF AND THE REMAINING PORTION WAS SNARED FROM BELOW USING FEMORAL ACCESS. THE LEAD WAS REMOVED AND REPLACED. DURING THE LV LEAD EXTRACTION, THE RIGHT ATRIAL (RA) LEAD DISLODGED AND WAS REPOSITIONED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641694 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R 4196 LEAD