BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2911784 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16202
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 3, 2012
    Report Date
    February 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE THRESHOLDS HAVE RISEN AND INTERMITTANT CAPTURE HAS BEEN NOTED. THE PATIENT WILL BE HAVING A MASECTOMY IN JANUARY AND THE LEAD WILL BE REVISED SOMETIME AFTER THAT PROCEDURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD HAS BEEN SURGICALLY ABANDONED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED WITH NO ISSUES. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE LEAD HAD BEEN INTERMITTENTLY GIVING HIGH IMPEDANCE. THERE IS NO EVIDENCE OF NOISE AND ALL OTHER MEASUREMENTS ARE GOOD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED MONITORING THE LEAD OR BRINGING THE PATIENT IN FOR ISOMETRICS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18777 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0144

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R 1851| E110| 0144| T165| 5068