BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2911247 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15991
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 28, 2012
    Report Date
    November 28, 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

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD WAS DISCARDED AFTER THE EXPLANT PROCEDURE AND WILL NOT BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SHORTLY AFTER THE IMPLANT OF THIS LEFT VENTRICULAR LEAD, LOSS OF CAPTURE AND HIGH PACING THRESHOLDS WERE NOTED DUE TO A SUSPECTED LEAD DISLODGMENT. A PROCEDURE WAS PERFORMED TO EXPLANT AND REPLACE THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17137 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R