BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3904779 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11116
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 27, 2014
    Report Date
    April 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM RECEIVED A SHOCK. DURING EVALUATION IT WAS DETERMINED THAT THIS SYSTEM EXHIBITED NOISE AND OVERSENSING ON THE RIGHT VENTRICULAR (RV) CHANNEL. SENSING AND THRESHOLDS ARE STABLE; HOWEVER, THE PACE IMPEDANCE MEASUREMENTS HAD SUDDEN INCREASED FROM 698 OHMS TO 1,722 OHMS. POCKET MANIPULATION WAS PERFORMED AND NOISE WAS RECREATED. IT WAS BELIEVED THAT THIS RV LEAD WAS FRACTURED. THE PATIENT IS HOSPITALIZED AND BEING MONITORED FOR INAPPROPRIATE SHOCKS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED CONFIRMING THAT A REVISION PROCEDURE HAD BEEN PERFORMED, AND A LEAD FRACTURE WAS IDENTIFIED APPROXIMATELY 10 CENTIMETERS FROM THE LEAD CONNECTOR AND NOT VISIBLE UNDER FLUOROSCOPY. THE LEAD WAS ALSO TESTED THROUGH THE PACING SYSTEM ANALYZER (PSA), WHICH CONFIRMED NOISE, LOSS OF CAPTURE AND PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE LEAD WAS SURGICALLY CAPPED AND ABANDONED. A NEW LEAD WAS SUCCESSFULLY PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383421 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0286

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4542| 0693| 0286| P108| MISMATCH