BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3904904 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11259
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    July 11, 2013
    Report Date
    June 19, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT THE PHYSICIAN PLANNED TO BRING THE PATIENT IN FOR DEFIBRILLATION THRESHOLD (DFT) TESTING, AND WOULD REPLACE THE LEAD IF NECESSARY, BASED ON THE OUTCOME OF THE DFTS. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION. A FIELD REPRESENTATIVE FROM THE DEVICE MANUFACTURER CONTACTED THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE AND REPORTED DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED. WITH A 31 JOULE SHOCK, THE SHOCK IMPEDANCE MEASUREMENT WAS 120 OHMS. IT HAD BEEN 62 OHMS AT IMPLANT AND IN THE DAILY SHOCK LEAD IMPEDANCE TESTS, THE IMPEDANCE MEASUREMENTS WERE BETWEEN 49-134 OHMS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT CONFIRMED THE SHOCK IMPEDANCE MEASUREMENT WAS HIGH. HOWEVER, IT WAS REPORTED THE PHYSICIAN PLANNED TO CONTINUE TO MONITOR THE LEAD AT THIS TIME. NO CHANGES WERE MADE TO THE LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD AND ASSOCIATED NON-BOSTON SCIENTIFIC DEVICE EXHIBITED INCREASED SHOCK IMPEDANCE MEASUREMENTS. ALERTS IN THE PATIENT'S REMOTE MONITORING SYSTEM WERE ISSUED WHEN THE SHOCK IMPEDANCE REACHED 102 OHMS. THE ALERT SETTING IN THE DEVICE WAS INCREASED TO 130 OHMS AND THE SYSTEM CONTINUED TO BE MONITORED. NINE MONTHS LATER, A NEW ALERT WAS ISSUED AND THE SHOCK IMPEDANCE MEASUREMENT WAS 132 OHMS. IT WAS REPORTED THAT THE INCREASE HAD BEEN GRADUAL. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED PERFORMING DEFIBRILLATION THRESHOLD (DFT) TESTING TO ENSURE A SHOCK WOULD CONVERT THE PATIENT. IT WOULD BE THE PHYSICIAN'S DISCRETION TO REVISE THE LEAD OR CONTINUE TO MONITOR. IT WAS NOTED THAT NO NOISE WAS OBSERVED ON THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384192 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 325 MO Life Threatening| R 0181