BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2060114 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05559
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 29, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, NO RETURN OF PRODUCT IS INTENDED. 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 THIS LEFT VENTRICULAR LEAD WAS DISLODGED. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS REMOVED AND REPLACED. NO ADVERSE PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4554

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention