BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2951444 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00096
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 2, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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).

    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 UNIPOLAR IMPEDANCE WAS HIGHER THAN THE BIPOLAR IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. DURING THE REVISION PROCEDURE, LOSS OF CAPTURE WAS NOTED WHEN CONNECTED TO THE DEVICE. THE LEAD WAS REMOVED AND RETESTED WITH GOOD RESULTS, BUT THREE ATTEMPTS WERE MADE INTO THE DEVICE HEADER WHICH RESULTED IN IMPEDANCE MEASUREMENTS OF NO CAPTURE, INTERMITTENT CAPTURE, AND LOSS OF CAPTURE. AT ONE TIME, UNDEFINED IMPEDANCE WAS MEASURED. THE PHYSICIAN FELT THE LEAD HAD BEEN COMPROMISED DURING THE PROCEDURE. THE RV LEAD WAS CAPPED AND WAS REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55889 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4092-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R