BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910754 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16515
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 18, 2012
    Report Date
    November 18, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT' HOME REMOTE MONITOR DETECTED HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCES FOR THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. CLINIC EVALUATION WAS DONE AND ALL VECTORS YIELDED > 125 OHM SHOCK LEAD IMPEDANCE MEASUREMENTS. THERE WAS NO NOISE NOTED, AND CAPTURE THRESHOLDS AND PACING IMPEDANCES WERE NORMAL. SUBSEQUENTLY, SURGICAL INTERVENTION WAS PERFORMED. THE LEAD TO HEADER CONNECTIONS WERE EXTENSIVELY EVALUATED AND NOTED TO BE SECURE. THE LEAD WAS REMOVED FROM THE HEADER AND THE TERMINAL PINS WERE VISUALLY EVALUATED AND NO ABNORMALITIES WERE IDENTIFIED. THE PHYSICIAN THEN RECONNECTED THE LEAD TO THE DEVICE AND THE LEAD WAS MANIPULATED AROUND THE YOKE. WITH THIS MANEUVER THE SHOCK LEAD IMPEDANCE WAS MEASURED AND IMPEDANCES FROM 50 TO > 125 OHMS WERE OBTAINED. THERE WAS NO NOISE ON THE RATE/SENSE PORTION OF THE LEAD DURING THIS. THIS LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS IMPLANTED; THE ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18218 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R E110| 4086| A155| 0185| 0158