BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 2911165 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15646
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    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 DURING A ROUTINE FOLLOW-UP, THE IMPEDANCE MEASUREMENTS ON THE RIGHT ATRIAL (RA) LEAD COULD NOT BE OBTAINED. ADDITIONALLY, THERE WAS LOSS OF CAPTURE. THE X-RAY REVEALED THAT THE LEAD HAD DISLODGED. AS A RESULT, THE LEAD WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17606 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 0296| 4096| F111