BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1042408 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34223
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 7, 2008
    Report Date
    June 9, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES INFORMED THE LOCAL SALES REPRESENTATIVE THAT THE CROSS TALK IS LIKELY DUE TO THE PROXIMITY OF THE DISTAL COIL THE TRICUSPID VALVE/ATRIUM AND RECOMMENDED THAT THE RV LEAD SHOULD BE REPOSITIONED FURTHER AWAY FROM THE TRICUSPID VALUE OR IMPLANT A SEPARATE PACE/SENSE LEAD. TECHNICAL SERVICES WAS INFORMED THAT THE PHYSICIAN WAS RELUCTANT TO IMPLANT ADDITIONAL HARDWARE IN THIS PATIENT. THE REPRESENTATIVE REPORTED THAT THE P-WAVE MORPHOLOGY WAS LARGE ON THE SHOCK CHANNEL. TECHNICAL SERVICES SUGGESTED THAT PERHAPS THE HV LEADS WERE REVERSED IN HEADER. THE REPRESENTATIVE WILL HAVE THE PHYSICIAN CONFIRM THIS WHEN NEW LEAD IS IMPLANTED. BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD WAS EXPLANTED/REPLACED. THE HV TERMINAL PINS OF THE CHRONIC LEAD WERE NOT PHYSICALLY REVERSED IN THE HEADER. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT IN LATE-MAY 2017. THIS LEAD IS CURRENTLY UNDERGOING LABORATORY TESTING. THE LEAD WAS RETURNED TO BOSTON SCIENTIFIC'S QUALITY ASSURANCE LABORATORY SEVERED (3-TERMINAL LEG SEGMENTS). SETSCREW MARKS WERE IDENTIFIED ON ALL 3-SEGMENTS. THE PROXIMAL HV DBS CABLE WAS PULLED TO THE POINT OF FRACTURE NEAR THE DISTAL END OF THE TERMINAL PIN (CABLE NOT RETURNED. IT WAS CONCLUDED BASED ON X-RAY REVIEW THAT THIS OBSERVED DAMAGE OCCURRED AT THE TIME OF THE EXTRACTION PROCEDURE. A RESISTANCE WAS COMPLETED TO ASSESS THE LEAD SEGMENTS ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THIS TEST WERE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL SALES REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS IMPLANTABLE CRT-D DEVICE AND IMPLANTABLE TRANSVENOUS RV DEFIBRILLATION LEAD WAS EXHIBITING INTERMITTENT CROSSTALK FOLLOWING POCKET CLOSURE. THE LOCAL SALES REPRESENTATIVE REPORTED THAT THE DISTAL COIL OF THE LEAD IS PART WAY THROUGH THE TRICUSPID VALVE. SUBSEQUENTLY, TECHNICAL SERVICES WAS NOTIFIED THAT THIS PATIENT IS PACEMAKER DEPENDENT AND WAS EXPERIENCING ASYSTOLIC EPISODES. ALL LEAD DIAGNOSTIC VALUES WERE NORMAL. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT THE TIME OF THE PROCEDURE, MODEL#4538 WAS NOT IMPLANTED DUE TO DIAPHRAGMATIC STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R THE DEVICE H210/212652 WAS IMPLANTED 07-MAR-2008| THE DEVICE 4538/165143 WAS IMPLANTED 07-MAR-2008| THE DEVICE H210/ WAS IMPLANTED| THE DEVICE H217/711627 WAS IMPLANTED