BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3961742 · Received July 28, 2014

    Report

    Report Number
    2124215-2014-14592
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 11, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE (OOR), SHOCKING LEAD IMPEDANCE MEASUREMENT OF MORE THAN 125 OHMS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CLINIC WILL BE MONITORING CHANGES IN IMPEDANCE. NO INTERVENTION WAS PERFORMED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439355 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR T167| 4017| 1853| 0185