BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3062203 · Received April 16, 2013

    Report

    Report Number
    2649622-2013-05084
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 PRODUCT: 4076 IMPLANTABLE PACING LEAD (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED APPROXIMATELY TWO AND A HALF WEEKS POST IMPLANT THAT THE PATIENT HAD A POSSIBLE PERFORATION. THE LOW VOLTAGE LEAD HAD NO CAPTURE IN BIPOLAR OR UNIPOLAR CONFIGURATION AT MAXIMUM OUTPUT. IT WAS NOTED THAT BOTH UNIPOLAR AND BIPOLAR SENSING WERE ACCEPTABLE, NO CHEST PAIN HAD BEEN NOTED SINCE IMPLANT AND THE CHEST X-RAY WAS UNREMARKABLE. THE LEAD WAS GOING TO BE REPOSITIONED AND 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
    163950 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| L| R ADDR01 IMPLANTABLE PULSE GENERATOR