BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3862349 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06981
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD VARIABLE AND UNSTABLE THRESHOLDS. THE RA LEAD WAS FOUND TO CAUSE PHRENIC NERVE AND DIAPHRAGMATIC STIMULATION. THE RA LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED SUCCESSFULLY. IT WAS ALSO REPORTED THAT DUE TO THE RA LEAD REVISION, THE RIGHT VENTRICULAR (RV) LEAD WAS MOVED AND REPOSITIONED TO A MORE APICAL LOCATION. THE PATIENT WAS PACEMAKER DEPENDENT AND AS A RESULT OF THE RV LEAD REPOSITION, THE PATIENT¿S BLOOD PRESSURE DROPPED. THE PATIENT¿S HYPOTENSION WAS MEDICALLY TREATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337790 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R ADDRS1 IPG, 5076-58 LEAD