BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1951486 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22999
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 25, 2010
    Report Date
    November 25, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW LEFT VENTRICULAR LEAD WAS SUCCESSFULLY IMPLANTED. THE EXPLANTED LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD EXHIBITED INCREASED THRESHOLDS DUE TO DISLODGEMENT. A REVISION PROCEDURE WAS PERFORMED; THE LEAD WAS ATTEMPTED TO BE REPOSITIONED WITHOUT SUCCESS. THE DECISION WAS MADE TO REMOVE AND REPLACE THE LEAD. THE EXPLANTED LEAD WAS DISCARDED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NORMAL MEASUREMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS 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 Required Intervention