BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 1791120 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-07010
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    March 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON LEAD RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A LEAD-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) OUTER INSULATION BREACHED; DISTAL SEGMENT RETURNED AND ANALYZED. (B)(4) INNER INSULATION BREACHED; DISTAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEADS WERE RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4024 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other E1DR01 IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD