BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3041131 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01059
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 6, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    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.

    Additional Manufacturer Narrative · 1

    WHEN THE REVISION HAS BEEN PERFORMED, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS ATRIAL LEAD EXPERIENCED INAPPROPRIATE SHOCKS AND PRESENTED TO THE HOSPITAL. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED FOR ASSISTANCE TO DETERMINE THE REASON FOR THE INAPPROPRIATE SHOCK, BUT THOUGHT IT MAY BE DUE TO THIS LEAD DISLODGMENT. AN X-RAY WAS PERFORMED AND THE DATA WAS PROVIDED TO TECHNICAL SERVICES. THE PATIENT REMAINS HOSPITALIZED WHILE THE ANALYSIS IS BEING PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. A DECISION HAS BEEN MADE TO PERFORM A LEAD REVISION IN THE NEAR FUTURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS REMOVED AND DISCARDED BY THE FACILITY. ONLY THE RIGHT VENTRICULAR LEAD WAS REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. TECHNICAL SERVICES REVIEWED THE DATA AND DETERMINED THAT THIS LEAD IS LOCATED IN A VERY HIGH POSITION. IT WAS ALSO THOUGHT THE PATIENT WITH THIS LEAD MAY BE SUFFERING FROM A TWIDDLERS SYNDROME AS THE LEADS ARE WRAPPED AROUND THE DEVICE CAUSING TRACTION ON BOTH LEADS WHICH LIKELY CONTRIBUTED TO THIS LEAD DISLODGMENT. IT WAS ALSO THOUGHT THE TIP OF THIS LEAD IS TOUCHING THE RIGHT VENTRICULAR LEAD PROXIMAL COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143313 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R