BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6163833 · Received December 9, 2016

    Report

    Report Number
    2649622-2016-15822
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 19, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169550766
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 4068-58 LEAD, IMPLANTED: (B)(6) 1997, 310C27 X 2 TISSUE VALVE IMPLANTED: (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT A "FLUTTERING" SENSATION, AND THE RIGHT VENTRICULAR (RV) LEAD WAS NOT PACING AT THE HIGHEST OUTPUT AND THE THRESHOLDS HAD INCREASED. IN ADDITION, THE LEAD WAS NOT SENSING APPROPRIATELY AND EXHIBITED DIMINISHED R-WAVES. THE LEAD WAS PROGRAMMED OFF AND A CHRONIC LEAD WAS REUSED. AN X-RAY WAS PERFORMED AND CONFIRMED THAT THE RV LEAD HAD DISLODGED. A PROCEDURE WAS SCHEDULED TO REPOSITION THE LEAD. THE LEAD 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
    811818 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52 00643169550766

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R (B)(4) IPG