BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3053103 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04409
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 12, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    NOTAPVD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISLODGED. AS A RESULT, THE LEAD WAS SUCCESSFULLY REPOSITIONED. TWO DAYS LATER, THE LEAD HAD DISLODGED AGAIN. THE LEAD WAS SUCCESSFULLY REPOSITIONED A SECOND TIME. THE NEXT FOLLOW-UP REVEALED THAT THE RV LEAD HAD DISLODGED A THIRD TIME. THIS LEAD REMAINS IMPLANTED AND IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154599 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R