BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173188 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10323
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PRODUCTS WERE NOT RETURNED TO BOSTON SCIENTIFIC. A NEW PACING SYSTEM WAS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A REPLACEMENT PROCEDURE OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), A POCKET INFECTION WAS OBSERVED AND THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT THE RIGHT VENTRICULAR DEFIBRILLATION (RV) LEAD, WAS SURGICALLY ABANDONED. THE PATIENT'S POCKET WAS CLEANED AND THE PATIENT WILL BE MONITORED CLOSELY. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R