BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 5796155 · Received July 14, 2016

    Report

    Report Number
    2124215-2016-10390
    Event Type
    Injury
    Date Received
    July 14, 2016
    Date of Event
    June 23, 2016
    Report Date
    June 30, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    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 THE PACING IMPEDANCE MEASUREMENTS ON THIS RIGHT VENTRICULAR (RV) LEAD WERE HIGH AND OUT OF RANGE, AND NOISE WAS SEEN. THE SHOCK VALUES WERE NORMAL. NO FURTHER FOLLOW UP WAS SCHEDULED. THE PATIENT WAS NOT PACEMAKER DEPENDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    A REVISION TOOK PLACE, AND A NEW DEFIBRILLATION PORTION OF THE LEAD WAS IMPLANTED AND A NEW RA LEAD WAS CONNECTED TO THE EXISTING DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PERTINENT AS THIS RELATES DIRECTLY TO THE EVENT, AMENDED MDR TO AN SI REPORT DUE TO THE INTERVENTION ON IMPACT ON MDV REPORTING LN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447858 ENDOTAK ENDURANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0155

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R