BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3911801 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-11484
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LEAD HAS BEEN RETURNED. BOSTON SCIENTIFIC HAS CONCLUDED IT IS UNLIKELY THAT LEAD CHARACTERISTICS CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. 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 LEFT VENTRICULAR (LV) LEAD WAS DISLODGED. THE LV LEAD WAS EXPLANTED AND WAS REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391060 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R N160| 4555| 0293| 0296| 4136