BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210135 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07330
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 24, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS RETURNED, AND MET SPECIFICATION. A CONNECTION ISSUE WAS RULED OUT.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW AND EVALUATION OF THE DEVICE ANALYSIS DETERMINED THAT A LEAD CONNECTION ISSUE COULD NOT BE RULED OUT. UPON RECEIPT, LABORATORY ANALYSIS CONFIRMED THAT ALL SETSCREWS OPERATED NORMALLY, AND VISUAL INSPECTION AND TESTING OF THE LEAD PORTS DID NOT REVEAL ANY ISSUES. ALL ELECTRICAL TESTING WAS SUCCESSFUL, AND NO ISSUES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE MEASUREMENTS WERE NOTED DURING THE EXTENSIVE LABORATORY ANALYSIS PROCESS. AS A RESULT, IT IS NOT POSSIBLE TO DEFINITIVELY DETERMINE THE ROOT CAUSE OF THE HIGH IMPEDANCE MEASUREMENTS. HOWEVER, BECAUSE THE OUT-OF-RANGE MEASUREMENTS ONLY OCCURRED WITH THE NEW ENERGEN MODEL F141 DEVICE, WE SUSPECT THAT THE MODEL 0175 LEAD MAY NOT HAVE BEEN FULLY INSERTED IN THE HEADER OF THE DEVICE, OR THE SETSCREW MAY NOT HAVE BEEN FULLY SECURED. THIS COULD HAVE RESULTED IN AN INCOMPLETE ELECTRICAL CONNECTION AND THE OBSERVED HIGH, OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS. ADDITIONALLY, THE MODEL 0175 LEAD HAD NORMAL MEASUREMENTS WHEN IT WAS IMPLANTED WITH THE PATIENT'S PREVIOUS DEVICE, SO A LEAD ISSUE IS NOT SUSPECTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AFTER A NORMAL REPLACEMENT PROCEDURE OF THE DEVICE A NEW DEVICE AND PREVIOUSLY IMPLANTED RIGHT VENTRICULAR LEAD WAS CONNECTED AND OUT OF RANGE PACING IMPEDANCES WERE NOTED. THE POCKET WAS RE-OPENED TO PERFORM A LEAD REVISION, AND THIS RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED WHILE A NEW RIGHT VENTRICULAR LEAD WAS IMPLANTED. THE NEWLY IMPLANTED DEVICE WAS ALSO REPLACED AS AN ISSUE WITH THIS DEVICE COULD NOT BE CONFIRMED. THE DEVICE WILL BE RETURNED FOR ANALYSIS WHILE THE RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    -

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309671 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R