BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2170815 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09665
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 16, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A REVISION PROCEDURE WAS PERFORMED. A DECISION WAS MADE TO IMPLANT ANOTHER NON-BOSTON SCIENTIFIC EPICARDIAL LEAD AND THIS LEAD WAS EXPLANTED. POST PROCEDURE, NORMAL DEVICE FUNCTION WAS DETERMINED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THIS LEAD WAS SUCCESSFULLY IMPLANTED. SEVERAL HOURS POST PROCEDURE, A VENTRICULAR PERFORATION WAS SUSPECTED. A REVISION PROCEDURE WAS PERFORMED. ALTHOUGH THIS LEAD WAS FUNCTIONING NORMALLY, A DECISION WAS MADE TO IMPLANT A NON-BOSTON SCIENTIFIC EPICARDIAL LEAD. THE PATIENT REMAINED HOSPITALIZED AND MONITORED. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening