BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3040684 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00423
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    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 THE PATIENT WITH THIS DEVICE SYSTEM ENDURED AN INFECTION. A REVISION PROCEDURE WAS PERFORMED AND A FULL SYSTEM EXTRACTION WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. AN IMPLANT PROCEDURE WAS TO OCCUR AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143625 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4591

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R N119| H177| 5076| 4537| 0157| 1853| MISMATCH| 4591| 1488T| 0158