BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1863813 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16840
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD HAD DISLODGED. 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 4554

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention