BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990353 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08689
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 PRODUCT: 5076-45, LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FEELING TERRIBLE SO THEY WENT TO THE ER (EMERGENCY ROOM). IT WAS FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE, NON-CAPTURE, AND WAS SUSPECTED OF A POSSIBLE FRACTURE. THE LEAD WAS INACTIVATED AND A NEW LEAD WAS IMPLANTED ON THE PATIENT¿S OTHER SIDE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464485 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R SDR303B ICD