BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3993728 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09152
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 PRODUCTS: 5076-45 LEAD, IMPLANTED: (B)(6) 2006; YRIRHXC16115 STENT GRAPH, IMPLANTED: (B)(6) 2005; YRECHXC1655 STENT GRAPH, IMPLANTED: (B)(6) 2005; YRBRHXC2816135 STENT GRAPH, IMPLANTED: (B)(6) 2005. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH AT THE FIRST RIB /CLAVICLE LOCATION WHILE IN VIVO. THE PROXIMAL CONDUCTOR OF THE LEAD BECAME DISTORTED AT THE FIRST RIB/CLAVICLE LOCATION WHILE IN VIVO. THE OUTER INSULATION OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION. VISUAL ANALYSIS FOUND APPROXIMATELY 2 CENTIMETERS OF OUTER INSULATION WAS MISSING AT DISTANCE 18CM (PROXIMAL-WITHIN 20CM). BLOOD AND BODY TISSUE AND DISTORTION OF THE PROXIMAL CONDUCTOR APPEARED IN THIS AREA. THERE WAS ALSO A LOT OF BLOOD ALONG LEAD LENGTH. THE ANALYST NOTED: ALL THESE THINGS FOUND LEAD US TO CONCLUDE THAT THE OUTER INSULATION WAS BREACHED IN-VIVO/ CLAVICLE RIB CRUSH, AND IT DID CONTRIBUTE TO THE COMPLAINTS OF HIGH THRESHOLDS AND UNDERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LOSS OF CAPTURE IN THE RIGHT VENTRICULAR (RV) LEAD, AT MAXIMUM OUTPUT IN BOTH BIPOLAR AND UNIPOLAR. IT WAS FURTHER REPORTED THAT THE RV LEAD DID NOT SENSE THE PATIENT'S ESCAPE RATE, WHICH WAS IN THE 30'S, EVEN AFTER CHANGING THE SENSITIVITY. THE PATIENT WAS REPORTED TO BE INTOLERANT OF A HEART RATE IN THE 30'S. IT WAS DISCOVERED THAT THE LEAD HAD DISLODGED AND WAS FLOATING IN THE RV. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466969 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R SESR01 IPG