BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1853846 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-15134
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE LEAD HAS NOT BEEN RETURNED. IF THIS LEAD SHOULD BE RETURNED, ANALYSIS WOULD NOT BE REQUIRED AS THIS CLINICAL OBSERVATION CANNOT BE REPLICATED IN ANALYSIS. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO DISLODGEMENT. 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 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R N119| 4592| 0185| 4555| 4542| 4135