BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4131466 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14534
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    June 14, 2014
    Report Date
    July 19, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE FIELD. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BECOME AVAILABLE.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPT TO GATHER ADDITIONAL INFORMATION FROM THE FIELD CONCERNING THIS EVENT WERE UNSUCCESSFUL. THE CAUSE OF THE HIGH IMPEDANCE VALUE REMAINS UNKNOWN. 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

    ADDITIONAL INFORMATION PROVIDED FROM THE FIELD INDICATES SURGICAL INTERVENTION WAS PERFORMED AND THE RIGHT VENTRICULAR LEAD WAS ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND RIGHT VENTRICULAR LEAD EXHIBITED AN OUT OF RANGE PACING IMPEDANCE MEASUREMENT OF GREATER THAN 2000 OHMS. THE SYSTEM CONTINUES TO REMAIN IMPLANTED AND IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611806 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R E161