BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 1922492 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12967
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S11
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE OUTER INSULATION WAS BREACHED DUE TO ENVIRONMENTAL STRESS CRACKING; THE DISTAL SEGMENT WAS RETURNED FOR ANALYSIS. ALL CONDUCTORS WERE DISTORTED AND BLOOD/BODY FLUID WAS OBSERVED (NOT OBSTRUCTED). THE OUTER INSULATION WAS MELTED, HAD ENVIRONMENTAL STRESS CRACKING, WAS BREACHED CUT AND A WHITE SUBSTANCE WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS EXPLANTED DUE TO INFECTION. THE LEAD WAS 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4504M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R 262-16 COMPETITOR IMPLANTABLE PULSE GENERATOR