BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK

    MDR report key: 1871498 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17340
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 28, 2010
    Report Date
    April 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTD
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE EXTENDER SUBSEQUENTLY WAS INCLUDED IN A SYSTEM EXPLANT DUE TO A PATIENT INFECTION.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT'S REPORTING STATUS IS CHANGED TO SERIOUS INJURY FROM MALFUNCTION DUE TO MEDICAL INTERVENTION TO RESOLVE THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    A BOSTON SCIENTIFIC FIELD REPRESENTATIVE SUBSEQUENTLY REPORTED THAT THE OUT-OF-RANGE MEASUREMENTS BEGAN IN THE RV-TO-RA (RIGHT VENTRICULAR TO RIGHT ATRIAL) CONFIGURATION AFTER THE DEVICE WAS MOVED TO THE PATIENT'S ABDOMINAL AREA, AND EXTENDERS WERE USED BETWEEN THE DEVICE AND LEAD. IMPEDANCE MEASUREMENTS WERE NORMAL IN THE RV-TO-DEVICE AND TRIAD CONFIGURATIONS. A FLUOROSCOPY DID NOT SHOW ANY OBSERVABLE CONNECTION ISSUES. DEFIBRILLATION TESTING WAS CONDUCTED IN THE RV-TO-DEVICE CONFIGURATION AND PRODUCED NORMAL MEASUREMENTS. THE PHYSICIAN ELECTED TO LEAVE THE SYSTEM PROGRAMMED TO THAT CONFIGURATION AND USE REMOTE MONITORING TO FOLLOW FUTURE MEASUREMENTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD EXTENDER, A CHRONIC RIGHT VENTRICULAR (RV) LEAD AND RECENTLY-IMPLANTED DEVICE WERE ASSOCIATED WITH A REMOTE MONITORING ALERT FOR HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS WHEN THE PATIENT'S MONITORING SYSTEM WAS ACTIVATED. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) AND THE PATIENT'S PHYSICIAN DISCUSSED TROUBLESHOOTING TECHNIQUES, AND THE POSSIBILITY OF A CONNECTION ISSUE WITH TWO OR MORE OF THE PRODUCTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK IMPLANTABLE LEAD DTD CPI - DEL CARIBE 6952

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other| R (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)