BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950962 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23095
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 9, 2010
    Report Date
    December 16, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. SETSCREW MARKS WERE NOTED ON THE IS-1 TERMINAL PIN, AND THE DISTAL AND PROXIMAL HV TERMINAL PINS. NO DISCERNABLE SET SCREW MARKS WERE NOTED ON THE IS-1 RING. THE MEDICAL ADHESIVE WAS SEPARATED FROM THE GORE COVERING AT THE PROXIMAL END OF THE PROXIMAL SPRING ELECTRODE AND THE PROXIMAL SPRING WAS STRETCHED SLIGHTLY AT THIS POINT. BODILY FLUID WAS NOTED IN THE HELIX HOUSING AND THE HELIX WAS RETRACTED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS THE ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY OF THE LEAD. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. HELIX MECHANISM TESTING DID NOT PASS, NOTED TO BE MOST LIKELY DUE TO BODILY FLUID AND TISSUE NOTED IN THE HELIX HOUSING. WHEN THE BODILY FLUID AND TISSUE WERE LOOSENED FROM THE MECHANISM, THE HELIX WAS FUNCTIONAL. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS DEFIBRILLATION LEAD HAD DISLODGED AND WAS SUBSEQUENTLY EXPLANTED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    THE LEAD WAS LATER RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 288 MO Required Intervention 0185| E102