BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211097 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08751
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 2, 2013
    Report Date
    September 19, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP) THAT NOTED THE HIGH MEASUREMENT WAS 127 OHMS, AND THE IMPEDANCE PLOT OVER TIME WAS ERRATIC. THE LAST MEASURED SHOCK LEAD IMPEDANCE WAS 103 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THAT A RECURRENT HIGH, OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENT WAS RECEIVED. SUBSEQUENTLY INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT THE IMPEDANCES HAVE BEEN CHRONICALLY HIGH AND THERE WERE NO PLANS TO DO COMMANDED SHOCK TESTING AT THIS TIME. THE DEVICE SYSTEM REMAINS IN SERVICE AND THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING SYSTEM TRANSMITTED THAT A HIGH OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM HAD BEEN DETECTED. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THE RV LEAD IMPEDANCES HAVE REACHED 149 OHMS. A COMMANDED SHOCK IS NOW BEING CONSIDERED, BUT HAS NOT BEEN PERFORMED AT THIS TIME. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310947 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR E102| 0181