BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 2953006 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00862
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - (B)(4) THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. HOWEVER, THE DISTAL END OF THE ELECTRODE WAS COVERED IN BLOOD. THERE WAS APPARENT EXPLANT DAMAGE.

    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

    EVENT SUMMARY: (B)(4) - THE LEAD WAS RETURNED AND ANALYZED. THE OUTER INSULATION OF THE LEAD WAS BREACHED/CUT. THE INNER INSULATION WAS TORN. THE VISUAL SUMMARY NOTED THAT THE LEAD WAS STRETCHED AND THERE WAS APPARENT IMPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEFT VENTRICULAR (LV) LEAD COULD NOT BE USED DUE TO PATIENT ANATOMY. A NEW LEAD WAS IMPLANTED. A NEW RIGHT VENTRICULAR (RV) LEAD WAS CONNECTED AND NOISE WAS OBSERVED AS WELL AS INTERMITTENT SENSING AND INAPPROPRIATE INHIBITION OF PACING CAUSING ASYSTOLE AFTER BEING CONNECTED TO THE NEW DEVICE. THE IMPEDANCE ALSO DECREASED. THE DEVICE WAS TAKEN OUT OF THE POCKET AND THE LEADS DISCONNECTED. MEASUREMENTS TAKEN ON ALL LEADS WERE CONSISTENT WITH VALUES AT IMPLANT EARLIER. IT WAS THOUGHT THAT THERE WAS A HEADER ISSUE WITH THE DEVICE. A NEW DEVICE WAS CONNECTED AND AGAIN, NOISE WAS SEEN ON THE RV LEAD. THE RV LEAD WAS THEN EXPLANTED AND A NEW LEAD REIMPLANTED IN THE RIGHT VENTRICLE. THE LEADS WERE CONNECTED TO THE NEW DEVICE AND ALL MEASUREMENTS WERE FUNCTIONING NORMALLY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57581 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| L| R