BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991452 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08114
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: PRODUCT ID: ADDR01, IPG, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE LOOP RECORDER (ILR) SHOWED INAPPROPRIATE DETECTION OF ASYSTOLE ON NOISE EPISODES AND A LACK OF RECORDING ANY OF THE PATIENT¿S SYNCOPAL EPISODES. IT WAS NOTED THAT THE DEVICE WAS INTERROGATED AT THE REPLACEMENT PROCEDURE AND IT SHOWED NO AUTO OR PATIENT ACTIVATED EPISODES. THE DEVICE WAS EXPLANTED AND REPLACED WITH A PACEMAKER. IT WAS FURTHER REPORTED THAT AT THE REPLACEMENT PROCEDURE, UPON CLOSURE OF THE POCKET, THE ATRIAL LEAD WAS FOUND TO HAVE HIGH IMPEDANCE AND NO CAPTURE OR SENSING. AN X-RAY CONFIRMED THAT THE LEAD HAD FALLEN INTO THE VENTRICLE. THE POCKET WAS RE-OPENED AND THE LEAD WAS REPOSITIONED SUCCESSFULLY 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
    470174 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R 4076-58, LEAD