BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3761288 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08547
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS BEEN RETURNED. BOSTON SCIENTIFIC HAS CONCLUDED IT IS UNLIKELY THAT LEAD CHARACTERISTICS CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. 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 THIS RIGHT ATRIAL (RA) LEAD WAS DISLODGED. THE PATIENT REPORTED DIAPHRAGMATIC STIMULATION. FURTHER LOW SENSING VALUES AND HIGH PACING THRESHOLD MEASUREMENTS WERE NOTED BY THE PHYSICIAN. A FLUOROSCOPIC IMAGE CONFIRMED THE LEAD DISLODGEMENT. THIS RA LEAD WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS. A NEW COMPETITOR LEAD WAS IMPLANTED SUCCESSFULLY WITH GOOD LEAD MEASUREMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239291 FLEXTEND II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R F111| 0296| 4096| MISMATCH