BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 3041119 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01667
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DECISION WAS MADE TO NOT PERFORM A REVISION PROCEDURE AS THE PATIENT IS IN ATRIAL FIBRILLATION (AF). NO ACTION WILL BE TAKEN UNTIL THE HEART TRANSPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED. ADDITIONALLY, THE PROXIMAL COIL WAS DAMAGED. AS A RESULT, A REVISION PROCEDURE WAS ASCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143309 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1