BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210356 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08827
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 THIS PATIENT HAD TO BE EXTERNALLY RESCUED AS HIS DEVICE SYSTEM DID NOT CONVERT HIS RHYTHM. A SECOND RIGHT VENTRICULAR (RV) LEAD WAS PLACED IN THE PATIENT AND THE CHRONIC RV LEAD WAS REPOSITIONED IN AN EFFORT TO PROVIDE THERAPY. BOTH OF THESE RV LEADS HAD HIGH DEFIBRILLATION THRESHOLD (DFT). THE CHRONIC RV LEAD WAS REPOSITIONED TO THE AZYGOUS VEIN, THE DEVICE WAS PROGRAMMED TO A TRIAD CONFIGURATION AND NON CONVERSION WAS STILL BEING SEEN. THE PATIENT IS WEARING AN EXTERNAL LIFEVEST WHILE ON WAITING FOR A NEW HEART ON THE TRANSPLANT LIST. NO FURTHER INTERVENTION WAS PERFORMED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310477 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R 0181| MISMATCH| N119| 4136