BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140093 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17385
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    February 25, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECORDS INDICATE THIS SYSTEM REMAINS IN SERVICE WITHOUT FURTHER COMPLICATION. 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

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED IN TWO SEGMENTS, SEVERED 134 MILLIMETERS (MM) FROM THE TERMINAL PIN WITH SOME PORTION OF THE LEAD MISSING. VISUAL INSPECTION OF THE LEAD REVEALED A SEPARATION OF THE GORE¿ COVERING FROM THE MEDICAL ADHESIVE (MA) AT THE PROXIMAL END OF THE PROXIMAL SHOCKING COIL. ASSOCIATED WITH THIS WAS A STRETCHING OF THE PROXIMAL END OF THIS SHOCKING COIL. THE SEPARATION WAS A RESULT OF EXCESSIVE DRAG ON THE GORE AND THE SHOCKING COILS. UNDER NORMAL CIRCUMSTANCES, SEPARATION OF THE GORE COVERING WILL NOT IMPACT THE FUNCTIONALITY OF THE LEAD. ADDITIONALLY, CALCIFICATION ALONG WITH TISSUE WAS NOTED ON THE PROXIMAL SPRING ELECTRODE AND THE DISTAL SPRING ELECTRODE. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. AN X-RAY WAS PERFORMED WHICH DID NOT REVEAL ANY CONDUCTOR FRACTURES. ANALYSIS CONCLUDED THE RISE IN SHOCK IMPEDANCE MEASUREMENTS WAS LIKELY DUE TO THE BUILDUP OF CALCIFICATION ON THE SHOCKING COILS WHICH CREATES A NON-CONDUCTIVE BARRIER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS SYSTEM WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A GRADUAL INCREASE IN SHOCK IMPEDANCE MEASUREMENTS. IN CLINIC, HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE NOTED IN RV TO CAN CONFIGURATION AND RV TO RA CONFIGURATION. IN TRIAD MEASUREMENTS WERE ACCEPTABLE. A DEFIBRILLATION THRESHOLD (DFT) TEST WAS COMPLETED IN TRIAD WITH A 31 JOULE SHOCK WHICH SUCCESSFULLY CONVERTED THE PATIENT. MEASUREMENTS IN ALL CONFIGURATIONS WERE ACCEPTABLE FOLLOWING TESTING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619805 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention 4087| N118| H175| 4517