BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 1871139 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17319
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT LATITUDE DETECTED A RED ALERT FROM THIS TRANSVENOUS DEFIBRILLATION LEAD DUE TO OUT OF RANGE SHOCK IMPEDANCES OF GREATER THAN 125 OHMS. IT WAS NOTED THAT IT HAD BEEN STEADILY RISING OVER TIME. A REVISION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, SHOCK IMPEDANCES WERE NOTED TO BE NORMAL. IT WAS NOTED THAT CONDENSATION WAS OBSERVED INSIDE THE DISTAL COIL PORT, AND BLOOD IN THE PROXIMAL PORT OF THE DEVICE HEADER. IT WAS ALSO NOTED THAT THIS LEAD LOOKED NORMAL VIA FLUOROSCOPY, AND MEASUREMENTS WITH THE LEAD WERE NORMAL WITH THE PACING SYSTEM ANALYZER (PSA). THE PHYSICIAN THEREFORE REQUESTED A NEW DEVICE. TECHNICAL SERVICES (TS) NOTED IT WAS PHYSICIAN DISCRETION TO TRY A NEW DEVICE. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION. ADDITIONAL INFORMATION WAS PROVIDED THAT THE DECISION WAS MADE TO SURGICALLY CAP THIS LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0144

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention H179| 1788| 0144| 1850| 4087| E110