BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1043299 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33352
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 11, 2008
    Report Date
    November 10, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE BSC REP WERE UNSUCCESSFUL. AS OF TODAY, THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE AND LEAD REMAIN IN SERVICE WITHOUT ADDITIONAL COMPLICATION. IF ANY ADDITIONAL INFORMATION RELATED TO THIS INCIDENT BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE FOLLOWING THREE SEGMENTS OF THE LEAD WERE RETURNED: DF-1 DISTAL LEG WHICH WAS SEVERED AT SEVEN CM FROM THE TERMINAL PIN, DF-1 PROXIMAL LEG WHICH WAS SEVERED AT SEVEN CM FROM THE TERMINAL PIN AND THE IS-1 LEG WAS RETURNED SEVERED AT EIGHT CM FROM THE TERMINAL PIN. A SETSCREW MARK WAS NOTED ON ALL TERMINAL CONNECTORS. THE LEAD SEGMENTS WERE SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THE RETURNED PORTION OF THE LEAD'S ELECTRICAL PERFORMANCE WAS INTACT. NO FURTHER TESTING WAS PERFORMED ANALYSIS COULD NOT CONFIRM THE CLINICAL ALLEGATIONS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IMPLANTABLE RIGHT-VENTRICULAR LEAD, PROGRAMMED WITH DETECTION ENHANCEMENTS TO ON, DID NOT DELIVER THERAPY IN A VENTRICULAR RATE>ATRIAL RATE IS TRUE CONDITION. THE BSC REP AND CLINICIAN WERE CONCERNED THAT THE DEVICE WAS UNDERSENSING. TECHNICAL SERVICES (TS) DISCUSSED THE ONSET AND DETECTION ENHANCEMENT COMBINATIONS. TS RECOMMENDED A SAVE-TO-DISK AND MEMORY-DUMP BE COMPLETED AND SENT IN FOR ANALYSIS. THE BSC REPRESENTATIVE STATED THAT HE WOULD FAX IN THE STRIPS AND CALL TS BACK. FOLLOWING THIS INITIAL EVENT, THE PATIENT EXPERIENCED SEVERAL ATP ROUNDS FOLLOWED BY SHOCKS. A SHORT WHILE AFTER THAT, THE DEVICE EXHAUSTED THERAPY. TS RECOMMENDED THAT THE BSC REP WALK THROUGH DEVICE FUNCTION ONCE THERAPY IS EXHAUSTED. A PORTION OF THE LEAD WAS RETURNED FOLLOWING THE PATIENT'S DEATH. NO ALLEGATION WAS MADE AGAINST THE BOSTON SCIENTIFIC PRODUCT IN RELATION TO THE PATIENT'S DEATH. THE RETURNED PORTION OF THE LEAD WAS PUT THROUGH STANDARD ANALYSIS TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other THE DEVICE (B)(4) WAS IMPLANTED| THE DEVICE H170/362051 WAS IMPLANTED 10-FEB-2006| THE DEVICE (B)(4) WAS IMPLANTED| THE DEVICE 4542/106753 WAS IMPLANTED 10-FEB-2006