BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2781086 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13290
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 27, 2012
    Report Date
    February 23, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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) AND RIGHT VENTRICULAR LEAD DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WITH THE LAST YEAR. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT THE PATIENT WAS SEEN FOR FOLLOW. A 21 JOULE SHOCK WAS DELIVERED INTO THE SYSTEM WITH RESULTING NORMAL SHOCK IMPEDANCE MEASUREMENTS. THE SYSTEM WILL CONTINUE TO BE MONITORED. THE SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE SYSTEM DISPLAYED A HIGH, OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0127

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R T127| 1488T| 0127| E110| 1851