BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2790182 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14998
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. EVALUATION SUMMARY (B)(4): THE FULL LEAD IN SEGMENTS WAS RETURNED TO THE MANUFACTURER AND ANALYZED AND NO ANOMALIES WERE FOUND. ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED.) THE INNER TUBING WAS KINKED/BUCKLED AND OUTER INSULATION BREACHED CUT, HAD A WHITE SUBSTANCE AND HAD COSMETIC DEPRESSION. THE HELIX/LOBE WAS DISTORTED/BENT AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE LEAD HAD APPARENT EXPLANT DAMAGE. EVENT SUMMARY (B)(4): THE FULL LEAD IN SEGMENTS WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE DEFIBRILLATION CONDUCTOR WAS FRACTURED. THE DISTAL AND DEFIBRILLATION CONDUCTORS WERE DISTORTED AND THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED.) THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY. THE OUTER TUBING WAS KINKED/BUCKLED, AND THE OUTER TUBING OVERLAY MELTED AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKING (ESC.) THE OUTER TUBING HAD ESC BREACH/BREACH (NON-ELECTRICAL.) EXPOSED DEFIBRILLATION COIL HAD A WHITE SUBSTANCE. THE OUTER INSULATION HAD COSMETIC DEPRESSION AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE (OOR) AND VARIABLE SUPERIOR VENA CAVA (SVC) IMPEDANCE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIUM (RA) LEAD WAS WITHOUT CAPTURE OR SENSING AND FOUND TO BE DISLODGED IN THE ATRIUM UNDER X-RAY. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD PLACEMENT WAS IN A POOR ANATOMICAL POSITION. THEREFORE THE RV, RA, AND LV LEADS WERE REMOVED AND REPLACED WITH NEW LEADS. NO 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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD