BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2060025 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-06132
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 5, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMPEDANCE MEASUREMENTS CONFIRMED THERE HAVE BEEN MULIPTLE MEASUREMENTS LESS THAN 20 OHMS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED TROUBLESHOOTING WITH THE CALLER AS THE CONCERN IS A COMPROMISE IN THE HIGH VOLTAGE LEAD INSULATION RESULTING IN A POTENTIAL SHORT. IT DOES NOT APPEAR THAT INDUCTION TESTING WAS PERFORMED AT THE IMPLANT PROCEDURE. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ELEVEN MONTHS LATER NOTING THAT A RED ALERT WAS RECEIVED FROM THIS LEAD DUE TO HIGH RIGHT VENTRICULAR (RV) PACING IMPEDANCE MEASUREMENTS. A FRACTURE WAS SUSPECTED DUE TO THE OUT OF RANGE MEASUREMENTS AND SUSPECTED LOSS OF CAPTURE. THE PRESENTING ELECTROGRAMS (EGM) ALSO SHOWED VENTRICULAR RATE RESPONSE (VRR) PACING DUE TO NOISE ON THE RV CHANNEL WHILE THE SHOCK CHANNEL SHOWED WHAT LOOKED LIKE THE PATIENT'S SINUS RATE OF 60 BPM. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND REPLACED WITHOUT FURTHER INCIDENT. THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DETAILS WERE RECEIVED REGARDING THE REVISION PROCEDURE. AN X-RAY CONFIRMED A FRACTURE WHICH WAS LOCATED IN THE SUBCLAVIAN AREA. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS RECEIVED FOR A LOW SHOCKING IMPEDANCE FROM THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD. ADDITIONALLY, THERE WAS ONE EPISODE OF NON- SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) DUE UNDERSENSING OF NOISE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR (B)(4)| (B)(4)| (B)(4)