BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 2161217 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-08322
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR (B)(4) LABORATORY, VISUAL OBSERVATIONS INDICATED A COMPLETE LEAD WAS RETURNED. THE HELIX WAS RETRACTED, AND THERE WAS DRIED BLOOD IN THE HELIX HOUSING MECHANISM UP THROUGH THE LUMEN. THIS RA LEAD DID NOT PASS THE HELIX MECHANISM TEST, WHICH WAS MOST LIKELY DUE TO DRIED BLOOD IN THE HELIX MECHANISM. THE INITIAL ALLEGATION OF RA LEAD DISLODGEMENT WAS NOT CONFIRMED THROUGH ANALYSIS. ELECTRICALLY, THIS LEAD WAS FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING THE IMPLANT PROCEDURE OF THE ASSOCIATED LEFT VENTRICULAR (LV) LEAD, THIS RIGHT ATRIAL (RA) LEAD DISLODGED. ATTEMPTS WERE MADE TO PLACE THE LEAD AGAIN, BUT WERE UNSUCCESSFUL. IT WAS ALSO NOTED THERE WERE ABNORMAL IMPEDANCE MEASUREMENTS, WHICH COULD HAVE BEEN OUT OF RANGE. THIS RA LEAD WILL BE RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1