BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2952309 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00517
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 DURING THE IMPLANT, THE LEAD WAS POSITIONED IN THE RIGHT VENTRICULAR (RV) APEX AND THE HELIX WAS EXTENDED. WITHIN MINUTES THE PATIENT COMPLAINED OF CHEST TIGHTNESS AND THEIR BLOOD PRESSURE (BP) DECREASED. THE LEAD WAS REPOSITIONED TO THE RV SEPTUM. AN ECHOCARDIOGRAM VERIFIED THE PRESENCE OF PERICARDIAL EFFUSION. THE BP RETURNED TO BASELINE AND THE CHEST PRESSURE RESOLVED BY THE END OF PROCEDURE. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55827 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R