BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3041067 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02104
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    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

    IT WAS LATER REPORTED THAT THE POCKET WAS REOPENED AND THE HIGH VOLTAGE TERMINAL PINS WERE CONFIRMED TO BE REVERSED IN THE DEVICE HEADER. THE PINS WERE PLACED IN THE CORRECT PORTS, AND THIS RESOLVED THE ODD MORPHOLOGY THAT HAD BEEN SEEN ON THE SHOCK CHANNEL. THE CHRONIC RV LEAD AND THIS DEVICE REMAIN 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 IMMEDIATELY POST-IMPLANT, AFTER THE POCKET WAS CLOSED, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND CHRONIC RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED A MORPHOLOGY ON THE SHOCK CHANNEL THAT APPEARED ODD TO THE PHYSICIAN. IT WAS NOTED THAT THE SHOCK CHANNEL WAS PICKING UP THE P-WAVES FROM THE RIGHT ATRIAL (RA) LEAD. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED OPENING THE POCKET TO VERIFY LEAD CONNECTIONS AND TO PERFORM DEFIBRILLATION THRESHOLD (DFT) TESTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142805 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 4087| T165| 0185