BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2780609 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13079
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 12, 2012
    Report Date
    January 14, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    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

    ONLY THREE TERMINAL LEG SEGMENTS (IS-1, 66MM; DISTAL HV, 47MM; PROXIMAL HV, 46MM) WERE RETURNED TO BOSTON SCIENTIFIC'S QUALITY ASSURANCE LABORATORY. SET SCREW MARKS WERE IDENTIFIED ON ALL OF THE TERMINAL PINS (IS-1, DF(NEG), DF(POS) AND IS-1 RING). THE SEAL RINGS ARE LAID BACK AND ONE IS TORN. CUTS WERE NOTED IN THE INSULATION. THE SEGMENTS WERE PUT THROUGH AND PASSED ELECTRICAL CONTINUITY TESTING.

    Additional Manufacturer Narrative · 1

    A SAVE-TO-DISK WAS OBTAINED FROM THIS PATIENT'S MODEL#N141 DEVICE WHICH WAS INSERVICE UP UNTIL THE DEATH OF THIS PATIENT. THE LAST RECORDED EPISODE OCCURRED ON (B)(6) 2015 AT 11:21 AM. THE EPISODE WAS STORED FOR A VENTRICULAR TACHYCARDIA RATE OF (B)(6) BPM AND WAS NONSUSTAINED. A REVIEW OF THE TRENDS OVER A (B)(6) MONTH PERIOD PRIOR TO THE PATIENT'S DEATH SHOWED THAT ALL DIAGNOSTIC MEASUREMENTS WERE IN RANGE. ATRIAL LEAD IMPEDANCES WERE 430-500 OHMS, RV LEAD IMPEDANCES EARLIER IN THE YEAR WERE IN THE RANGE OF 1235-1450 OHMS, WITH A GRADUAL DECLINE TO A RANGE OF 990-1200 OHMS OVER THE LAST 3 MONTHS PRIOR TO DEATH, LV LEAD IMPEDANCES OF 600-820 OHMS, AND SHOCK LEAD IMPEDANCES OF 38-52 OHMS. THERE WERE NO ALERTS, FAULT CODES, ERROR MESSAGES, EVENTS, OR OUT-OF-RANGE MEASUREMENTS ON OR NEAR THE DATE OF DEATH. IT WAS CONCLUDED THAT THERE WAS NO REASONABLE EVIDENCE OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SYSTEM DETECTED A LOW SHOCK IMPEDANCE MEASUREMENT LESS THAN 20 OHMS. THE PATIENT WAS BROUGHT IN FOR FURTHER REVIEW. A PROCEDURE WAS PERFORMED TO VIEW THE LEADS UNDER FLUOROSCOPY AND TO PERFORM DEFIBRILLATION TESTING. THE PATIENT'S PHYSICIAN ELECTED TO CONTINUE TO MONITOR THE PATIENT. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION IN MID-NOVEMBER 2015 THAT THIS PATIENT HAD DIED ON (B)(6) 2015. THERE WERE NO REPORTED ALLEGATIONS OF LEAD MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    .

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R 1831| A135| 4244| E110