BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992663 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09736
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: 694758 LEAD IMPLANTED: 2009-(B)(6); 419478 LEAD IMPLANTED: 2005-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED COMPLAINING OF "WEIRD FEELINGS" IN THEIR CHEST AND RIGHT SIDE. IT WAS DETERMINED THAT THE PATIENT WAS SUFFERING FROM DIAPHRAGMATIC NERVE STIMULATION. THE DEVICE WAS INTERROGATED AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED A LACK OF SENSING. THE ATRIAL SENSITIVITY WAS ADJUSTED, IN WHICH THE RA LEAD THEN EXHIBITED INTERMITTENT SENSING. IT WAS ALSO NOTED THAT THE ATRIAL THRESHOLD HAD RISEN SINCE CHANGE-OUT. A CHEST X-RAY WAS PERFORMED REVEALING THAT THE RA LEAD HAD DISLODGED AND PULLED BACK. THE PHYSICIAN OPTED TO REPROGRAM AND TURN OFF THE RA LEAD, PROGRAMMING THE DEVICE TO VVI WITH THE VENTRICULAR SENSE RESPONSE PACING ON. THE RA LEAD REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471027 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention C4TR01 CRT-P