BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2173738 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10671
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 18, 2011
    Report Date
    October 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WILL BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED OR UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT BOSTON SCIENTIFIC, THIS LEAD WAS THOROUGHLY TESTED. THE REPORTED OBSERVATIONS FROM THE FIELD WERE CONFIRMED. A SEGMENT OF THE LEAD WAS RETURNED, MISSING BOTH THE PROXIMAL/TERMINAL END AND THE DISTAL/TIP END. BOTH THE OUTER AND INNER COILS WERE FRACTURED AT 343 MM AND A KINK IN THE OUTER INSULATION WAS OBSERVED AT THE FRACTURE SITE. THE LEAD SHOWED SIGNS OF CLASSIC FATIGUE AND TORSIONAL FATIGUE, LEADING TO DISCONTINUITY OF THE CONDUCTOR COILS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW-UP, THIS LEFT VENTRICULAR LEAD WAS FOUND TO HAVE ELEVATED IMPEDANCE AND THRESHOLD MEASUREMENTS. AN X-RAY SHOWED THAT THIS LEAD HAD AN INSULATION ISSUE. A FRACTURE WAS SUSPECTED. THIS LEAD WAS IMPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THIS LEAD WILL BE RETURNED TO BOSTON SCIENTIFIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R