BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2171229 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10385
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE LEAD HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. 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 DURING A ROUTINE IMPLANT PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD WAS ATTEMPTED TO BE IMPLANTED. THE PATIENT WAS REPORTING SYMPTOMS OF CHEST PAIN, RESULTING IN THE PROCEDURE TO BE ABORTED AND THE RV LEAD TO BE EXPLANTED. IT WAS DISCOVERED THAT THE PATIENT HAD A TAMPONADE AND SOME BLOOD WAS TAKEN OFF THE HEART. THE PATIENT RECOVERED WITH NO FURTHER ISSUES. THE RV LEAD WAS REPORTEDLY DISPOSED OF FOLLOWING THE PROCEDURE AND WOULD NOT BE RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening 4087