BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 1820562 · Received August 31, 2010

    Report

    Report Number
    2182208-2010-00609
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    July 23, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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) DISTAL CONDUCTOR FRACTURED; THE FULL LEAD IN SEGMENTS WAS RETURNED FOR ANALYSIS. THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID ON IT. THE OUTER INSULATION WAS BREACHED AND THE LEAD WAS FLEXED. THERE WAS A WHITE SUBSTANCE ON THE LEAD. (B)(4) DISTAL CONDUCTOR FRACTURED; PARTIAL LEAD IN SEGMENTS WAS RETURNED FOR ANALYSIS. THE DISTAL CONDUCTOR WAS DISTORTED AND THERE WAS BLOOD/BODY FLUID. THE OUTER INSULATION WAS TORN AND BREACHED. THE LEAD WAS FLEXED AND THERE WAS A WHITE SUBSTANCE ON THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL AND VENTRICULAR LEADS HAD HIGH OR UNSTABLE OR UNMEASURABLE THRESHOLDS. THE 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 EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4965 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR