BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173124 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10447
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    January 15, 2008
    Report Date
    June 13, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY ONLY THE TERMINAL PORTION OF THIS LEAD WAS RECEIVED. THE RETURNED PORTION WAS TESTED AND FOUND TO BE ELECTRICALLY CONTINUOUS INDICATING NO FRACTURE. HOWEVER, THERE WAS CORROSION OBSERVED ON THE IS-1 PIN. THIS FINDING COULD HAVE CONTRIBUTED TO THE CLINICAL OBSERVATIONS. THE CORROSION WAS LIKELY CAUSED BY RS- SET SCREW NOT BEING PROPERLY TIGHTEN DOWN ON THE TERMINAL PIN WHICH CREATED A SLIGHT GAP BETWEEN THE HEADER BLOCK AND TERMINAL PIN. THIS, ALONG WITH BODY FLUID CAN CAUSE CORROSION OF THE TERMINAL PIN OVER TIME. NO FURTHER ANALYSIS WAS PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS PATIENT IS SCHEDULED TO BE EVALUATED BY THE PHYSICIAN IN THE NEAR FUTURE. NO FURTHER PLAN OF ACTION AS BEEN REPORTED AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS LEAD HAS HIGH PACING THRESHOLDS AND CONTINUES TO EXHIBIT OUT OF RANGE PACING IMPEDANCES. THE PATIENT IS RELUCTANT TO UNDERGO A REPLACEMENT PROCEDURE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. SUBSEQUENT INFORMATION INDICATES THAT THIS PATIENT UNDERWENT A REVISION PROCEDURE AS THIS PRODUCT WAS RETURNED FOR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD PREVIOUSLY EXHIBITED AN INCREASED IN PACING IMPEDANCES; HOWEVER, WAS NOT FOUND TO BE OUT OF RANGE. SEVERAL YEARS LATER THE LEAD WAS FOUND TO BE FRACTURED AS IT HAD EXHIBITED AN ACUTE INCREASE IN PACE IMPEDANCE MEASUREMENTS, WHICH WERE OUT OF RANGE, GREATER THAN 3,000 OHMS AND LOSS OF CAPTURE. THE PATIENT WAS TO UNDERGO A REPLACEMENT PROCEDURE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening 0184| 4086| T180