BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3760895 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08887
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 17, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS RETURNED SEVERED AT 190 MM FROM THE TERMINAL PIN, ONLY THE PROXIMAL SEGMENT WAS RETURNED. THE LEAD SEGMENT WAS SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THIS SEGMENTS ELECTRICAL PERFORMANCE WAS INTACT. NO FURTHER TESTING WAS PERFORMED. ANALYSIS COULD NOT CONFIRM THE CLINICAL ALLEGATIONS OBSERVED IN THE FIELD BASED ON THE TESTING OF THE RETURNED LEAD SEGMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT-OF-RANGE PACING LEAD IMPEDANCE MEASUREMENT THAT WAS DETECTED VIA THE PATIENT¿S REMOTE MONITORING SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD IMPEDANCE WAS BETWEEN 1950 OHMS AND GREATER THAN 2,000 OHMS DURING THE DEVICE CHANGE OUT PROCEDURE AND SINCE ALL OTHER LEAD MEASUREMENTS WERE ACCEPTABLE, THE PHYSICIAN ATTRIBUTED THE IMPEDANCE VALUE TO THE AGE OF THE LEAD. THE PATIENT WILL CONTINUE TO BE MONITORED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND INDICATED THAT HIGH PACING LEAD IMPEDANCE CONTINUES TO BE INTERMITTENTLY OUT OF RANGE. THE PHYSICIAN HAS ELECTED TO CONTINUE TO MONITOR THIS ISSUE BUT TAKE NO ADDITIONAL ACTION AT THIS TIME. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED OVER TWO YEARS LATER FOLLOWING THE PATIENT'S DEATH OR AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240210 ENDOTAK ENDURANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0145

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR E141| 1782| 1488TC| T165| MISMATCH