BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 2041815 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01156
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    December 19, 2010
    Report Date
    January 13, 2011
    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

    NO FURTHER PATIENT EFFECTS WERE REPORTED. AN ATTEMPT WAS MADE TO RETRIEVE ADDITIONAL INFORMATION FROM THE FIELD CONCERNING THE FINAL OUTCOME OF THIS EVENT, HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED. 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 ATRIAL (RA) LEAD HAD INCREASING HEART FAILURE SYMPTOMS. DURING A FOLLOW-UP, IT WAS NOTED THE RA LEAD HAD DISLODGED. THE PATIENT WAS HOSPITALIZED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O