BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2914264 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00887
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 11, 2012
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION AVAILABLE FROM THE FIELD REPRESENTATIVE REVEALED THAT THIS LEAD HAS NOT BEEN RETURNED TO THEIR BIN FROM THE HOSPITAL. 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 LEAD WAS CAUSING DIAPHRAGMATIC STIMULATION AFTER THE PATIENT HAD RECENTLY FALLEN. DURING A ROUTINE FOLLOW-UP, THE ELECTROPHYSIOLOGIST (EP) FELT A MICRO-PERFORATION MAY HAVE OCCURRED. A SMALL DEFECT AROUND THE TIP OF THE LEAD WAS ALSO NOTED. THE LEAD WAS SUCCESSFULLY EXPLANTED FROM THE PATIENT AND REPLACED WITH ANOTHER LEAD. AN ECHO PERFORMED AFTER THE NEW LEAD WAS IMPLANTED SHOWED NO EFFUSION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20214 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| L| R 4088| 4087| S603