BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2150941 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06284
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    February 11, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR LEAD PRESENTED TO THE HOSPITAL WITH PAIN IN THEIR LEFT ARM. ULTRASOUND IMAGING REVEALED A THROMBUS IN THE LEFT SUBCLAVIAN VEIN THAT THE PHYSICIAN FELT WAS RELATED TO THE IMPLANT OF THE LEAD. THE PATIENT WAS PRESCRIBED HEPARIN. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention 4136| 0185| E110