BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4932555 · Received July 22, 2015

    Report

    Report Number
    2124215-2015-09548
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    October 1, 2014
    Report Date
    June 15, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS (>200 OHMS), WHICH WERE OBSERVED IN SEVERAL VECTOR CONFIGURATIONS. THE PATIENT HAD A POCKET REVISION PROCEDURE SHORTLY BEFORE THE IMPEDANCE MEASUREMENTS STARTED INCREASING. THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE CONSULTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). TS DISCUSSED THAT THE HIGH SHOCK IMPEDANCE MEASUREMENTS MAY BE DUE TO AN OPEN CIRCUIT CONDITION. TS ADVISED TO PERFORM IMPEDANCE TESTING IN ORDER TO VERIFY THE OPEN CIRCUIT CONDITION. THE FIELD REPRESENTATIVE INDICATED THAT THIS WOULD BE DISCUSSED WITH THE PHYSICIAN. THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE AT WHICH IT WAS FOUND THAT THE DF-1 PIN OF THE RV LEAD WAS NOT FULLY SECURED INTO THE HEADER. THE RV LEAD WAS FULLY INSERTED AND SECURED INTO THE HEADER. THE LEAD IMPEDANCE MEASUREMENTS AND DEFIBRILLATION THRESHOLDS THEREAFTER WERE FOUND TO BE IN NORMAL RANGES. THE RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS (>200 OHMS), WHICH WERE OBSERVED IN SEVERAL VECTOR CONFIGURATIONS. THE PATIENT HAD A POCKET REVISION PROCEDURE SHORTLY BEFORE THE IMPEDANCE MEASUREMENTS STARTED INCREASING. THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE CONSULTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). TS DISCUSSED THAT THE HIGH SHOCK IMPEDANCE MEASUREMENTS MAY BE DUE TO AN OPEN CIRCUIT CONDITION. TS ADVISED TO PERFORM IMPEDANCE TESTING IN ORDER TO VERIFY THE OPEN CIRCUIT CONDITION. THE FIELD REPRESENTATIVE INDICATED THAT THIS WOULD BE DISCUSSED WITH THE PHYSICIAN. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE REASON FOR THE PREVIOUS POCKET REVISION PROCEDURE WAS TO REPOSITION THE DEVICE, WHICH HAD MIGRATED DUE TO WEIGHT LOSS. TO ADDRESS THE HIGH SHOCK IMPEDANCE MEASUREMENTS, A LEAD REVISION PROCEDURE WAS DONE, AT WHICH IT WAS FOUND THAT THE DF-1 PIN OF THE RIGHT VENTRICULAR (RV) LEAD WAS NOT FULLY SECURED INTO THE HEADER. THIS LOOSE CONNECTION LIKELY OCCURRED AT THE PREVIOUS POCKET REVISION PROCEDURE. THE RV LEAD WAS FULLY INSERTED AND SECURED INTO THE HEADER. THE LEAD IMPEDANCE MEASUREMENTS AND DEFIBRILLATION THRESHOLDS WERE FOUND TO BE IN NORMAL RANGES AFTER THE PROCEDURE. THIS RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474912 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| R 4135| E110