BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 4210022 · Received October 29, 2014

    Report

    Report Number
    2124215-2014-19189
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    August 24, 2014
    Report Date
    November 5, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE DEVICE IS RETURNED ANALYSIS WILL BE PERFORMED AND THIS EVENT WOULD BE UPDATED.

    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.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW INTRINSIC RV AMPLITUDES, HIGH PACING THRESHOLD MEASUREMENTS AND LOSS OF CAPTURE. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE A LEAD DISLODGMENT WAS CONFIRMED THROUGH A FLUOROSCOPY. THE PHYSICIAN WAS UNABLE TO REPOSITION THE LEAD, THUS IT WAS EXPLANTED AND REPLACED WITH NO ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692396 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 4086| 4087| S603