BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4830109 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06272
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    February 21, 2015
    Report Date
    March 16, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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: 2311-36 DEVICE, IMPLANTED: (B)(6 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM FOR PRE-SYNCOPE (LIGHT HEADEDNESS AND NAUSEA). WHILE IN THE EMERGENCY ROOM, THEY CAPTURED A PAUSE ON THE ELECTROGRAM. INTERMITTENT LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD WAS ALSO NOTED. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, IT WAS DETERMINED THAT THE ATRIAL LEAD EXHIBITED HIGH IMPEDANCES WHILE BEING TESTED. THE ATRIAL 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
    380085 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R 6947-65 LEAD