BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2121689 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07812
    Event Type
    Injury
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. ANALYSIS FOUND THAT THE DEFIB CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID IN SEVERAL CONDUCTORS (NOT OBSTRUCTED) AND IN THE OUTER TUBING OVERLAY, THE INNER AND OUTER TUBING WAS KINKED/BUCKLED, THE OUTER TUBER OVERLAY WAS MELTED AND HAD COSMETIC ESC, THE OUTER INSULATION WAS TORN AND HAD A COSMETIC CUT, THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIB COIL, AND THERE WAS A COSMETIC DEPRESSION IN THE OUTER INSULATION. (B)(4) A PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. ANALYSIS FOUND THAT THE DISTAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE PROXIMAL CONDUCTOR WAS MELTED, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, AND THERE WAS A COSMETIC DEPRESSION IN THE OUTER INSULATION.

    Description of Event or Problem · 1

    THE ATRIAL AND RIGHT VENTRICULAR LEADS WERE REMOVED DUE TO POCKET INFECTION AND WERE RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R 7289 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD