BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2052871 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03826
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    June 21, 2010
    Report Date
    February 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AFTER THE IMPLANT PROCEDURE OF THIS LEFT VENTRICULAR (LV) THIS PATIENT DEVELOPED A PNEUMOTHRAX. A DRAIN WAS APPLIED TO DRAIN THE FLUID. THE LEAD REMAINS IMPLANTED.

    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 P107| 0185| 4548| 4096| 4555