BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211049 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08719
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    February 7, 2011
    Report Date
    April 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    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 A PACING IMPEDANCE MEASUREMENT HAD BEEN DETECTED ON THIS RIGHT VENTRICULAR (RV) LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD REMAINED IMPLANTED AND IN SERVICE. OVER TWO YEARS LATER, ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RV LEAD HAD PRESENTED WITH NOISE THAT WAS LEADING TO OVERSENSING AND THE DELIVERY OF INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS. IN ADDITION, THE PACING IMPEDANCE MEASUREMENTS WERE VARIABLE BETWEEN 400 AND BELOW 200 OHMS. A LEAD REVISION WAS PERFORMED AND DUE TO THE PATIENT'S ANATOMY, A NEW RV LEAD COULD NOT BE IMPLANTED. AS A RESULT, THE IS-1 PORTION OF THIS LEAD WAS CAPPED AND A NEW PACE/SENSE LEAD WAS SUCCESSFULLY IMPLANTED. THIS RV LEAD REMAINS IN SERVICE FOR DEFIBRILLATION PURPOSES ONLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310723 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R H170| 4470| 0158| 4538| N119