BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911843 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-17207
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    October 23, 2012
    Report Date
    April 11, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS AVAILABLE, 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 WHEN THIS RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED THE SHOCK LEAD IMPEDANCE READINGS WERE NOTED TO BE NORMAL WHEN MEASURED WITH THE PACING SYSTEM ANALYZER (PSA), BUT WHEN CONNECTED TO THIS ICD THE MEASUREMENTS WERE HIGH BUT WITHIN RANGE. THE FIELD REPRESENTATIVE CONSULTED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND IT WAS RECOMMENDED TO EVALUATE THE CONNECTIONS AND TO CONSIDER EVALUATING THE SYSTEM WITH A COMMANDED 1.1J SYNCHRONIZED SHOCK. SUBSEQUENTLY A 1.1J AND A 31J SHOCK WERE DELIVERED AND THE SHOCK LEAD IMPEDANCES WERE 96 AND 92 OHMS RESPECTIVELY. AT THIS TIME, THIS ICD AND NEW RV LEAD REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S HOME REMOTE MONITORING SYSTEM DETECTED A HIGH, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE MEASUREMENT. ADDITIONAL INFORMATION WAS REQUESTED FROM THE FIELD REPRESENTATIVE. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN IS AWARE OF THE SITUATION AND WAS NOT CONCERNED AS THE READINGS AT IMPLANT WERE ULTIMATELY OKAY WHEN SYSTEM WAS TESTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S HOME MONITORING SYSTEM TRANSMITTED HIGH SHOCK LEAD IMPEDANCE ON THIS SYSTEM HAD DETECTED AGAIN. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE INFORMATION WITH THE FIELD REPRESENTATIVE ALONG WITH POTENTIAL CAUSES. THE PLAN IS TO CONTINUE TO MONITOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED. REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17840 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 0180| 7288| E143| 5594| 6949