BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1072045 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03825
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    March 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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: INNER INSULATION BREACHED; DISTAL SEGMENT RETURNED AND ANALYZED IT WAS REPORTED THE LEAD WAS EXPLANTED AND REPLACED DUE TO SENSING DIFFICULTY, NO CAPTURE AND AN APPARENT FRACTURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. LOW IMPEDANCE WAS ALSO REPORTED. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION INSULATION DEGRADATION/DETERIORATION INSULATION DEVICE WAS OUT OF SPECIFICATION IN A MANNER THAT RELATES TO EVENT CAPTURE, FAILURE TO LEAD(S), FRACTURE OF INSITIVITY IMPEDANCE, LOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS EXPLANTED AND REPLACED DUE TO SENSING DIFFICULTY, NO CAPTURE AND AN APPARENT FRACTURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. LOW IMPEDANCE WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention P1501DR IMPLANTABLE PULSE GENERATOR