BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2053038 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05748
    Event Type
    Injury
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 DEPRESSION; FULL LEAD IN SEGMENTS RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS PRESENT IN/ON THE PROXIMAL CONDUCTOR, AND THE INNER INSULATION HAD COSMETIC MIO. THE OUTER INSULATION WAS KINKED/BUCKLED, MELTED, AND BREACHED CUT. IT ALSO HAD COSMETIC ESC AND COSMETIC DEPRESSION. (B)(4) INNER INSULATION BREACHED ESC; FULL LEAD IN SEGMENTS RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS PRESENT IN/ON THE PROXIMAL CONDUCTOR, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, AND THERE WAS INNER INSULATION COSMETIC MIO. THE OUTER INSULATION HAD BREACHED AND COSMETIC ESC, WAS TORN, AND HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SYSTEM WAS UPGRADED TO AN ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR), AND LEAD REMOVAL WAS REQUIRED TO GAIN VENOUS ACCESS. THE LEADS SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS WERE 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 29 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR