BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3243297 · Received July 23, 2013

    Report

    Report Number
    2124215-2013-10502
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE (SLI) MEASUREMENTS OF GREATER THAN 200 OHMS. THE VECTOR WAS IN TRIAD CURRENTLY AND EVERYTHING SHOWED OOR SLI OF GREATER THAN 200 OHMS. LEAD FRACTURE SEEMED UNLIKELY BASED ON THE AGE OF THE LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT SURGICAL INTERVENTION WAS PERFORMED. UPON OPENING THE POCKET AND REMOVING THE DEVICE, NOISE WAS NOTED ON THE RIGHT VENTRICULAR PACE/SENSE EGM. THERE WERE NO STORED EVENTS WITH NOISE PRIOR TO THE POCKET BEING OPENED. THE PHYSICIAN TUGGED ON EACH LEG OF THE RV LEAD, AND THE PACE/SENSE TERMINAL LEG WAS PULLED OUT OF THE HEADER DUE TO A LOOSE SET SCREW. EACH OF THE HIGH VOLTAGE LEGS WERE NOTED TO BE SECURE WITHIN THE HEADER. THE RV PACE/SENSE LEG WAS RECONNECTED AND THE SET SCREW WAS TIGHTENED. THE HIGH VOLTAGE LEGS WERE REMOVED FROM THE HEADER, RESEATED, AND THE SET SCREWS WERE RETIGHTENED. TESTING THROUGH THE DEVICE YIELDED NORMAL MEASUREMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342950 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R E141| 0184