BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2911394 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15966
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 21, 2012
    Report Date
    December 3, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. 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 PATIENT'S HOME MONITORING EQUIPMENT DETECTED A BOTH A HIGH OUT OF RANGE SHOCK IMPEDANCE AND A LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN IS AWARE OF THIS ALERT AND WILL PLAN TO ADDRESS THE LEAD ISSUE IN THE COMING MONTHS. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT WAS SEEN SHORTLY AFTER THE LEAD IMPEDANCE ISSUE WAS FOUND. AT THAT TIME THE PHYSICIAN ELECTED TO EXPLANT THE LEAD, DURING THE EXPLANT, THE LEAD BROKE APART AND THE LEAD DISTAL COIL REMAINS INSIDE OF THE PATIENTS HEART. THE REMAINDER OF THE LEAD WAS EXPLANTED AND REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17365 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0155

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R E110| 0155| 1861| 1388T