BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1771416 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13334
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED FOR ANALYSIS, AND WHEN ANALYSIS IS COMPLETED, A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, WITH THIS RIGHT VENTRICULAR (RV) LEAD, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE OBTAINING ACCESS. DURING THE EXTRACTION FROM THE CEPHALIC VEIN INTO THE SUBCLAVIA, IT WAS NOTED THAT THE LEAD APPEARED CRUSHED IN THE MIDDLE OF THE DISTAL COIL SPIRAL. IT WAS BELIEVED THE LEAD MAY HAVE HAD AN EXISTING WEAKNESS PRIOR TO IMPLANT. THIS LEAD WAS NOT IMPLANTED, AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO 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 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R