BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2173856 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10726
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING RETURN AND COMPLETION OF LAB ANALYSIS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REPORTED THE LEAD WAS DISCARDED AT THE MEDICAL FACILITY AND THUS WILL NOT BE RETURNED FOR A POST MARKET EVALUATION TO ASSESS ROOT CAUSE. IF NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEFT VENTRICULAR LEAD WAS HOSPITALIZED FOR AN EVALUATION. THE MEDICAL ASSESSMENT CONFIRMED LOSS OF CAPTURE AT MAXIMUM OUTPUTS AND THE PHYSICIAN SUSPECTED THE LEAD HAD DISLODGED. TO DATE, THE PATIENT REMAINS HOSPITALIZED FOR A PLANNED REVISION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, SURGICAL INTERVENTION CONFIRMED A FRACTURED LEAD. THE PRODUCT WAS EXPLANTED IN THE ABSENCE OF ADVERSE EFFECTS AND ANOTHER BOSTON SCIENTIFIC LEAD SUCCESSFULLY IMPLANTED. THE EXPLANTED LEAD IS INTENDED TO BE RETURNED FOR A POST MARKET EVALUATION.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention