BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1855033 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09095
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 10, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    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 WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDING: NO ANOMALIES FOUND. ELECTRICAL TESTING TO DETERMINE CONTINUITY OF THE CONDUCTOR(S) PASSED. VISUAL EXAMINATION NOTED PROXIMAL CONDUCTOR WAS DISTORTED, AND BLOOD/BODY FLUID WAS PRESENT ON/IN THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED). A CUT WAS EVIDENT THROUGH THE OUTER INSULATION MATERIAL AT MEDIAL SECTION, AND LEAD WAS STRETCHED. APPARENT EXPLANT DAMAGE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN IMPLANT ATTEMPT, THE PASSIVE FIXATION LEAD COULD NOT BE IMPLANTED DUE THE ANATOMY OF THE HEART. CONSEQUENTLY, THE LEAD WAS WITHDRAWN, AND AN ACTIVE FIXATION LEAD WAS IMPLANTED UNEVENTFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention