BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2780458 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13113
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    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

    A NEW COMPETITOR LEFT VENTRICULAR LEAD WAS SUCCESSFULLY IMPLANTED. THE EXPLANTED LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC. 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 A FEW DAYS POST IMPLANT, THIS LEFT VENTRICULAR LEAD EXHIBITED NO AMPLITUDE AND NO THRESHOLD MEASUREMENTS. A CHEST X-RAY WAS PERFORMED AND CONFIRMED THAT THE LEAD HAD DISLODGED. A REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS ATTEMPTED TO BE REPOSITIONED; HOWEVER, ADEQUATE POSITION AND MEASUREMENTS COULD NOT BE OBTAINED. THE DECISION WAS MADE TO REMOVE AND REPLACE THE LEAD WITH A COMPETITOR LEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL 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 Hospitalization| R