BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 1921614 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12612
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    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. EVALUATION SUMMARY: (B)(4) PRELIMINARY ANALYSIS REVEALED OUTER INSULATION BREACHED (CLAVICLE-RIB CRUSH); THE FULL LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS IN OR ON HELIX MECHANISM AND SLEEVE HEAD. NO ELECTRICAL ANOMALIES WERE OBSERVED. (B)(4) NO ANOMALIES WERE FOUND; THE DISTAL SEGMENT WAS RETURNED FOR ANALYSIS. THE PROXIMAL CONDUCTOR WAS DISTORTED, PROXIMAL CONDUCTOR HAD BLOOD OR BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION WAS MELTED, AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD NO CAPTURE AND HAD BEEN CHRONICALLY DISLODGED. IT WAS ALSO REPORTED THAT THE VENTRICULAR LEAD EXHIBITED SOME NOISE ACCORDING TO THE PHYSICIAN AND MAY HAVE BEEN FRACTURED. BOTH LEADS WERE EXPLANTED AND REPLACED. 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 SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4074 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention KDR901 IMPLANTABLE PULSE GENERATOR