BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3050007 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-05389
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 3, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    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'S HOME MONITORING EQUIPMENT DETECTED A LOW OUT OF RANGE SHOCKING IMPEDANCE, AND NOISE FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. THE LEAD REMAINS IN SERVICE. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT ANOTHER LOW OUT OF RANGE SHOCKING IMPEDANCE WAS DETECTED. THIS PATIENT NO LONGER HAS HEALTH INSURANCE AND HAS NO PLANS TO INTERVENE AT THIS POINT WITHOUT IT. THE DEVICE SYSTEM REMAINS IMPLANTED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE AND RIGHT VENTRICULAR (RV) LEAD WERE REMOVED FROM SERVICE DUE TO MUSCLE STIMULATION, OVERSENSING AND DURING DEFIBRILLATION THRESHOLD (DFT) TEST A SHOCK WAS UNABLE TO BE DELIVERED THROUGH THE DEVICE. AN ERROR CODE WAS NOTED AND AS A RESULT THE DEVICE WAS EXPLANTED AND THE LEAD WAS SURGICALLY ABANDONED. BOTH WERE SUCCESSFULLY REPLACED WITHOUT ISSUE. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149031 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R E102| T135| 0147