BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3864857 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07479
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 13, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. THE PROXIMAL AND DISTAL CON DUCTORS OF THE LEAD BECAME EXTRINSICALLY FRACTURED DUE TO A CUT. THE INNER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. ELECTRICAL TESTS ON THE PROXIMAL PORTION FAILED. ELECTRICAL TESTS ON THE DISTAL PORTION PASSED WITH DESTRUCTIVE TESTING.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 PRODUCT: 457453, LEAD, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM WITH SYMPTOMS OF LIGHTHEADEDNESS. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND UNSTABLE THRESHOLDS, HIGH IMPEDANCE, AND CONTAINED A POSSIBLE FRACTURE. THE RV LEAD WAS EXPLANTED AND REPLACED. ADDITIONALLY, THE ATRIAL LEAD EXHIBITED NO CAPTURE AND WAS 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
    338184 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407458

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R ADDRL1 IPG