BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4131762 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14177
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 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). 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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES. A HIGH ENERGY SHOCK WAS DELIVERED AND RETURNED NORMAL IMPEDANCE VALUES. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT AND NOT PERFORM ANY SURGICAL INTERVENTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612938 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0171

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4542| 4480| P107| 0171