BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2171622 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10230
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 16, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    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

    ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCTS REMAIN 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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RETURNED SEVERED AT 37 AND 60 CM FROM THE IS-1 TERMINAL PIN WITH THE TIP SECTION OF THE LEAD NOT RETURNED. VISUAL INSPECTION NOTED THAT MISSING SETSCREW MARKS ON THE TERMINAL PIN SUGGESTED IMPROPERLY INSERTED LEAD. RESISTANCE AND PRESSURE TESTS WERE COMPLETED ON THE RETURNED PORTIONS TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. ANALYSIS DETERMINED THAT THE CLINICAL OBSERVATIONS WERE LIKELY DUE TO AN IMPROPERLY INSERTED LEAD INTO DEVICE HEADER.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THREE MONTHS LATER THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR CONTINUE TO DISPLAY HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THE PRODUCTS REMAIN IMPLANTED AND WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT UNDERWENT A REVISION PROCEDURE. IT WAS REVEALED THAT THE RV LEAD WAS NOT FULLY INSERTED IN THE HEADER OF THE ICD. THE LEAD WAS RE-INSERTED SUCCESSFULLY AND NO FURTHER COMPLICATIONS WERE OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN-SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS SYSTEM CONTINUED TO EXHIBIT OUT OF RANGE IMPEDANCE MEASUREMENTS. THE PATIENT WAS BROUGHT INTO THE CLINIC FOR EVALUATION AND THERE WAS ONE EPISODE OF NOISE STORED. AN X-RAY WAS PERFORMED AND IT WAS REPORTED THAT THERE WAS A POTENTIAL INCOMPLETE CONNECTION ISSUE. THE PATIENT WAS TO UNDERGO A REVISION PROCEDURE IN THE NEAR FUTURE.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATES THAT THIS LEAD WAS EXPLANTED AFTER THE PATIENT'S SYSTEM WAS DOWNGRADED FROM AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TO A PACEMAKER.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DISPLAYED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS AFTER LESS THAN TWO MONTHS OF IMPLANT TIME. UPON DEVICE INTERROGATION, THE LEAD IMPEDANCE MEASUREMENTS WERE NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| R E102