BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 4131459 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-13549
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 29, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RV LEAD REMAINS IMPLANTED AND IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT TWO DAYS AFTER THIS RV LEAD WAS REPOSITIONED, THE PATIENT PRESENTED WITH A HEART RATE OF 35 BPM. THE PATIENT DID NOT EXPERIENCE SYNCOPE AS A RESULT. A CHEST X-RAY WAS PERFORMED AND REVEALED THAT THE RV LEAD WAS IN THE ATRIUM. ANOTHER REVISION WAS PERFORMED AND THIS RV LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED AT THE CLINIC AFTER EXPERIENCING PRESYNCOPE DURING A CARDIAC REHABILITATION SESSION. THE PATIENT STATED THAT WHEN THE THERAPIST PULLED HIS ARM, HE STARTED FEELING DIZZY. THE DEVICE WAS INTERROGATED AND REVEALED INTERMITTENT LOSS OF RV CAPTURE WHEN THE PATIENT MOVED HIS ARM. THE PACING IMPEDANCE MEASUREMENT WAS 480 OHMS. A CHEST X-RAY WAS TAKEN AND THE LEAD APPEARED TO BE FINE. A DISLODGEMENT WAS DETERMINED AND A REVISION PROCEDURE WAS PERFORMED. THE RV LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611314 FLEXTEND II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 4097| K184| 4096