BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3912208 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-12448
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). THIS LEAD COULD NOT BE RETURNED DUE TO POLICIES OF THE FACILITY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THAT THIS RIGHT ATRIAL (RA) LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED. NO ADDITIONAL 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
    390882 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4086| 4087| K063