BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3922075 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13003
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 2, 2014
    Report Date
    March 28, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION NOTED THAT 3 TERMINAL CONNECTORS WERE RETURNED SEVERED APPROXIMATELY 5 CENTIMETERS (CM) FROM THE TERMINAL PIN. RESISTANCE TESTING WAS COMPLETED TO ASSESS ELECTRICAL PERFORMANCE. THE RETURNED PORTIONS OF THE LEAD WERE FOUND TO BE ELECTRICALLY CONTINUOUS. LABORATORY ANALYSIS DID NOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW SHOCKING LEAD IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS. TRIAD WAS PERFORMED AND NORMAL IMPEDANCE MEASUREMENT WAS NOTED. THE WIRELESS ELECTROGRAM (EGM) SHOWED A LITTLE NOISE BUT THE REST OF THE PARAMETERS WERE FINE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NOISE WAS NOT REPRODUCED DURING ISOMETRICS. LEAD MEASUREMENTS WILL BE CLOSELY MONITORED THROUGH REMOTE MONITORING SYSTEM AND A RE-EVALUATION WAS SCHEDULED. AT THIS TIME THERE IS NO EVIDENCE THAT INTERVENTION HAS BEEN PERFORMED TO RESOLVE THIS ISSUE. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DIED APPROXIMATELY TWO YEARS LATER WITH NO ADDITIONAL INFORMATION LINKING THE PRODUCT TO THE PATIENT DEATH. A PORTION OF THE LEAD WAS RETURNED AND THE REMAINING PORTION OF THE LEAD REMAINS SURGICALLY ABANDONED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401679 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR T165| 4469| E163