BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170005 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09508
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 24, 2011
    Report Date
    July 20, 2015
    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

    IN THE ABSENCE OF A RETURNED PRODUCT, BOSTON SCIENTIFIC REMAINS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). LABORATORY ANALYSIS WAS PERFORMED ON THE RETURNED PROXIMAL SEGMENT WHICH MEASURED APPROXIMATELY 270 MM: THE TIP SEGMENT OF THE LEAD WAS NOT RETURNED. SETSCREW MARKS WERE OBSERVED ON ALL TERMINALS PINS; HOWEVER, NO DISCERNIBLE SETSCREW MARKS WERE NOTED ON THE RING. VISUAL INSPECTION SHOWED THE TRILUMEN INSULATION WAS ABRADED THROUGH ALL THREE LUMENS, AT THE END OF THE RETURNED SEGMENT: 260-270 MM FROM THE TERMINAL PIN. ADDITIONALLY, WEBBING DAMAGE WAS NOTED BETWEEN ALL THREE CONDUCTORS IN THIS SAME LOCATION. THE LEAD EXTERNAL MATERIAL ON ALL THREE CONDUCTORS, APPEARED TORN AND/OR ABRADED. THE DISTAL AND PROXIMAL HIGH VOLTAGE CONDUCTORS APPEARED FRACTURED AT THIS SAME LOCATION. MICROSCOPIC ANALYSIS INDICATED THE DAMAGE WAS INITIATED BY A LOCALIZED COMPRESSIVE STRESS. THE RATE SENSE CONDUCTOR WAS ALSO DEFORMED HOWEVER INTACT IN THIS AREA. ANALYSIS OF THE RETURNED SEGMENT WAS SUGGESTIVE OF LEAD DAMAGE INDUCED, DUE TO THE LEAD LOCATION AND RESULT OF ENTRAPMENT WITHIN THE CLAVICLE, FIRST-RIB REGION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE CLINICAL FOLLOW-UP, NOISE AND LOW PACING IMPEDANCE VALUES WERE EXHIBITED WITH THIS RIGHT VENTRICULAR LEAD; SHOCK IMPEDANCE OBSERVED WITHIN A NORMAL RANGE. DAILY MEASUREMENTS WERE REVIEWED AT WHICH TIME A GRADUAL DECREASE IN RV PACING IMPEDANCE HAD BEEN OBSERVED. A REVIEW OF STORED DATA CONFIRMED MORE THAN 500 EVENTS, WITH A MAJORITY DUE TO NON-SUSTAINED EPISODES IN THE ABSENCE OF SHOCK THERAPY. ADDITIONALLY, NOISE WAS CONFIRMED ON THE RV LEAD AND THE PHYSICIAN INDICATED AN X-RAY WOULD BE PERFORMED AT A LATER DATE. SUBSEQUENTLY, THE PATIENT WAS ADMITTED DUE TO AN INAPPROPRIATE SHOCK WITH INTERROGATION CONFIRMING NOISE PRESENCE ON THE SHOCK CHANNEL. THE X-RAY REVEALED POTENTIAL LEAD DAMAGE JUST BELOW THE CLAVICLE REGION. DURING SURGICAL INTERVENTION, THE LEAD WAS SURGICALLY ABANDONED AND ANOTHER LEAD SUCCESSFULLY IMPLANTED IN THE ABSENCE OF ADDITIONAL ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    SUBSEQUENTLY, A PARTIAL LEAD SEGMENT WAS RECEIVED FOR ANALYSIS FOLLOWING LEAD REMOVAL DUE TO INFECTION (SEE REPORT- 2124215-2015-07957).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention