BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3904184 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09698
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    February 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FIELD. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCES GREATER THAN 2,000 OHMS AT ROUTINE FOLLOW-UP. ALL OTHER MEASUREMENTS WERE WITHIN NORMAL RANGE AND X-RAY OF THE LEAD WAS UNREMARKABLE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED PERFORMING ADDITIONAL TESTING TO DETERMINE HOW TO PROCEED. THE PATIENT IS NOT PACEMAKER DEPENDENT AND NO REVISION IS PLANNED AT THIS TIME. THE PHYSICIAN PLANS TO ADMINISTER COMMANDED SHOCKS TO ASSESS THE PATIENT'S SYSTEM IN THE FUTURE AND DETERMINE FURTHER COURSE OF ACTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS RV LEAD AND ICD CONTINUED TO EXHIBIT HIGH OUT OF RANGE PACE IMPEDANCES UPON FOLLOW-UP. ALL OTHER LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS AND NO EPISODES OF NOISE WERE RECORDED TO THE DEVICE. THE PHYSICIAN ELECTED TO PERFORM A REVISION PROCEDURE WHEREIN THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD IS NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383399 ENDOTAK ENDURANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0145

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R F102| 0145