BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1951488 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22963
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    May 13, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS INACTIVELY IMPLANTED. 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 NEW INFORMATION THAT AN X-RAY WAS PERFORMED AND A FRACTURE WAS CONFIRMED ON THIS DEFIBRILLATION LEAD. UNDER FLUOROSCOPY, THE WIRE WAS OBSERVED TO BE OUTSIDE OF THE LEAD INSULATION. A LEAD REVISION WAS PLANNED, BUT NOT YET PERFORMED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WENT INTO THE CLINIC FOR FURTHER EVALUATION AND THE LEADS WERE PROGRAMMED OFF AND THE DEVICE WAS DEACTIVATED. THE PATIENT STATED THAT HE HAS HAD NOTHING, BUT PROBLEMS SINCE THE NEW DEVICE WAS IMPLANTED. THE PATIENT ALSO REPORTED SYMPTOMS OF PAIN AND SWELLING. NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS ISSUED FOR THIS DEVICE AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD INDICATING SHOCK IMPEDANCE WAS GREATER THAN 125 OHMS. FURTHER INFORMATION WAS RECEIVED THAT A REIVEW OF DAILY MEASUREMENTS IN LATITUDE REVEALED RV AND LEFT VENTRICULAR (LV) PACE IMPEDANCE WERE ALSO INTERMITTENTLY SPIKING BUT HAVE NOT GONE OUT OF RANGE. TECHNICAL SERVICES (TS) DISCUSSED THE POSSIBILITY OF CLAVICULAR CRUSH OR AN IMPACT FRACTURE. TS DISCUSSED BRINGING THE PATIENT IN FOR FURTHER EVALUATION AND TROUBLESHOOTING. IT WAS ALSO NOTED THAT THERE WERE MULTIPLE NON-SUSTAINED EPISODES IN THE ARRHYTHMIA LOGBOOK WHICH HAVE NOISE ON THE LEAD CHANNEL. ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE AND LEADS REMAIN IN SERVICE.

    Description of Event or Problem · 1

    THE BOSTON SCIENTIFIC REPRESENTATIVE WAS NOT AWARE OF ANY INTERVENING ACTION. ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE AND LEADS REMAIN IN SERVICE.

    Description of Event or Problem · 1

    AN INVASIVE REVISION PROCEDURE WAS PERFORMED, AND THE RV LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE PROCEDURE.

    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 66 YR Hospitalization| R (B)(4)| (B)(4)| (B)(4)| (B)(4)| MISMATCH| (B)(4)| (B)(4)