BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211330 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09213
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 3, 2013
    Report Date
    October 15, 2018
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING EQUIPMENT DETECTED A HIGH OUT OF RANGE SHOCKING IMPEDANCE FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. THERE ARE NO PLANS FOR INTERVENTION AT THIS TIME. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TESTING WAS PERFORMED IN AN EFFORT TO LOWER THE SHOCK LEAD IMPEDANCES WHICH CONTINUE TO BE OUT-OF-RANGE (OOR). TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL ALERTS FOR CONTINUED HIGH SHOCK IMPEDANCES HAVE BEEN FOUND. AT THIS TIME THERE ARE NO PLANS FOR INTERVENTION AND LEAD CALCIFICATION IS BELIEVED TO BE THE CAUSE OF THE CONTINUED OUT-OF-RANGE (OOR) IMPEDANCE MEASUREMENTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THIS RV LEAD HAS CONTINUED TO DISPLAY HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED DELIVERING A 41 J COMMANDED SHOCK TO DETERMINE THE TRUE SHOCK IMPEDANCE VALUE. THE PHYSICIAN ELECTED TO CONTINUE TO MONITOR THE PATIENT AND SYSTEM THOUGH IN-CLINIC CHECKS AND REMOTE MONITORING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311758 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R T135| E102| 0185