BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSVENE

    MDR report key: 1700040 · Received May 27, 2010

    Report

    Report Number
    2182208-2010-00232
    Event Type
    Death
    Date Received
    May 27, 2010
    Date of Event
    April 9, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S1
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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) OUTER INSULATION SEPARATION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    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) OUTER INSULATION BREACHED MIO, COSMETIC ESC AND DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH IN HOSPICE, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. RETURNED PAPERWORK INDICATES THE PATIENT DIED WITH CARDIOPULMONARY ARREST AND CORONARY ARTERY DISEASE. FOLLOW UP WITH THE CLINIC REPORTED THERE WERE NO DEVICE ALLEGATIONS AS RELATES TO THE PATIENT'S DEATH. DEVICE WAS "TURNED OFF BECAUSE HE WAS IN HOSPICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENE IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6936 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD