BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2053606 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04431
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    G050163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R 4460| 4461| N119| 4554| 4512| 4464| (B)(4)| 4592| 0184| 4135| 1241