BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3212955 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09733
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    -

    Additional Manufacturer Narrative · 1

    UPON FURTHER INFORMATION THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    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

    INFORMATION WAS SUBSEQUENTLY RECEIVED THAT THIS LEAD WAS SURGICALLY ABANDONED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP A LOSS OF CAPTURE WAS NOTED ON THIS RIGHT VENTRICULAR LEAD. IT WAS NOTED THAT THIS RIGHT VENTRICULAR LEAD HAD DISLODGED. A REPOSITIONING PROCEDURE WILL BE SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    -

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313086 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R