BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3904796 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10120
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 27, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS REPROGRAMMED AND REMAINS IMPLANTED. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT, THIS LEFT VENTRICULAR LEAD DISPLAYED LOSS OF CAPTURE. ACCEPTABLE SENSING AND IMPEDANCE MEASUREMENTS WERE OBTAINED. ALL PACING VECTORS RESULTED IN ATRIAL CAPTURE AND NO LEFT VENTRICULAR CAPTURE. LEAD DISLODGEMENT WAS SUSPECTED. THE DEVICE WAS REPROGRAMMED TO MINIMIZE LEFT VENTRICULAR PACING. A REVISION PROCEDURE IS INTENDED AT A FUTURE DATE, HOWEVER, HAS NOT BEEN SCHEDULED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS EXPLANTED AND REPLACED. NO RETURN OF THIS PRODUCT IS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383003 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R N142| 0292| 4555| 4136