BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1851813 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14173
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    February 3, 2010
    Report Date
    July 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACING SYSTEM WAS EXPLANTED AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC CRM. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD WAS CONFIRMED FRACTURED AT THE PROXIMAL LEVEL THROUGH FLUOROSCOPY. A REVISION PROCEDURE WAS PERFORMED; THE LEAD WAS STABLE IN THE TARGET VESSEL, THEREFORE, THE DECISION WAS MADE TO REPAIR THE LEAD WITH AN ADAPTOR. THE ADAPTED LEAD WAS LEFT IMPLANTED WITH OPTIMAL VALUES OF PACING THRESHOLD, IMPEDANCE AND SENSING. ON (B)(6) 2010 AN EXTRACTION PROCEDURE OF THE LEAD WAS PERFORMED. AFTER OPENING THE POCKET, IT WAS NOTED THAT THERE WAS A LOCAL INFECTION. THE DECISION WAS MADE TO EXPLANT THE ENTIRE PACING SYSTEM. A NEW PACING SYSTEM WAS TO BE IMPLANTED IN THE NEAR FUTURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention