BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2041811 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01007
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    April 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THERE IS NO ADDITIONAL INFORMATION AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE PATIENT PASSED AWAY. THE LEAD WAS EXPLANTED AND HAS BEEN RETURNED FOR ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE TERMINAL CONNECTORS OF THE LEAD WERE RETURNED AND ANALYZED. THE DF-1 DISTAL LEG WAS RETURNED, SEVERED 6 CENTIMETERS FROM THE PIN. THE DF-1 PROXIMAL LEG WAS RETURNED, SEVERED 5 CENTIMETERS FROM THE PIN. THE IS-1 LEG WAS RETURNED, SEVERED 6.5 CENTIMETERS FROM THE PIN. SETSCREW MARKS WERE NOTED ON ALL TERMINAL CONNECTORS. THE PORTIONS OF THE LEAD WERE DETERMINED TO BE ELECTRICALLY CONTINUOUS. THE CLINICAL OBSERVATIONS WERE NOT ABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT OF RANGE PACING IMPEDANCES. THE PATIENT'S HEATH CARE PROVIDER (HCP) STATED THAT THE PACING IMPEDANCES FOR THE LEAD HAD BEEN STEADILY RISING OVER THE LAST COUPLE OF MONTHS. THE HCP STATED THE PATIENT WAS INTERESTED IN A DO NOT RESUSCITATE (DNR) STATUS AND AN ACTION PLAN WAS TO BE DISCUSSED WITH THE PATIENT'S FOLLOWING PHYSICIAN. THERE WERE NO ADVERSE PATIENT EFFECTS. THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0145

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening (B)(4)| 4053| 1851| 0145| T125