BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4150832 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-15848
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    December 23, 2013
    Report Date
    August 19, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    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 THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A RISE IN SHOCK IMPEDANCE FROM 60 TO 100 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT HIGHER SHOCK IMPEDANCE WAS DUE TO SINGLE COIL LEAD AND THAT GRADUAL RISE IS NOT A CONCERN. THE PATIENT WAS CONTINUED TO BE MONITORED. HOWEVER, ADDITIONAL INFORMATION RECEIVED THAT RECENTLY THE SHOCK IMPEDANCE MEASURES 110 TO 125 OHMS AND DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED AT 21 JOULES WITH 70 OHMS. TS DISCUSSED TROUBLE SHOOTING OPTIONS. FURTHER INVESTIGATION INDICATED THAT THE CAUSE WAS UNDETERMINED AND WILL CONTINUE TO MONITOR. HOWEVER, DFT WILL AGAIN BE PERFORMED IF SHOCK IMPEDANCE WILL MEASURE GREATER THAN 145 OHMS. THE SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632429 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 195 MO Life Threatening| R 0181| E102