BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780141 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12356
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THE DEVICE REMAINS IN SERVICE. 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, IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) LEAD, RECEIVED SHOCK THERAPY WHICH DID NOT TERMINATE THE DETECTED ARRHYTHMIA. THE ARRHYTHMIA WAS SUCCESSFULLY TERMINATED FOLLOWING DELIVERY OF EXTERNAL DEFIBRILLATION. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE INTERROGATED THE DEVICE AND A FAULT CODE WAS DISPLAYED INDICATING A SHORTED LEAD CONDITION HAD OCCURRED. A MANUAL CAPACITOR REFORMATION WAS ATTEMPTED BUT WAS NOT COMPLETED. ANOTHER FAULT CODE WAS NOTED THAT INDICATED THAT DEVICE CHARGING HAD TIMED-OUT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED EXPLANT OF THE DEVICE AND LEAD AS THE PATIENT IS NO LONGER PROTECTED. THE DEVICE AND LEAD SHOULD BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R A135| 0148| 4480| E110