BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4163322 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12388
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 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: 407652, LEAD, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE FOLLOW-UP THE PATIENT'S RIGHT ATRIAL (RA) LEAD HAD INSULATION DAMAGE WITH A COMPLETE FRACTURE VISUALIZED BY X-RAY. ALSO, THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE AND OVERSENSING. MULTIPLE VENTRICULAR HIGH RATE EPISODES WERE NOTED FOR THAT LEAD. THE RA LEAD AND WAS CAPPED AND REPLACED, AND LATER REMOVED. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED 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
    643516 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R ADDR01 IPG