BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3771551 · Received April 24, 2014

    Report

    Report Number
    2124215-2014-09101
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 8, 2014
    Report Date
    March 13, 2014
    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 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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOW SHOCK LEAD IMPEDANCE MEASUREMENT OF LESS THAN 20 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED AN OFFICE FOLLOW UP FOR THE PATIENT. TS FURTHER DISCUSSED POSSIBLE CAUSE AND PROVIDED TROUBLESHOOTING OPTIONS. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL MEASUREMENTS WERE IN NORMAL RANGE DURING CLINIC CHECK. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249103 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 1388TC| 0175| T165| E110