BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2920894 · Received January 17, 2013

    Report

    Report Number
    2124215-2013-01115
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED PACING INHIBITION AND LOSS OF CAPTURE DUE TO A DISLODGEMENT. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED. DURING THIS PROCEDURE THE SUTURE SLEEVE WAS OBSERVED TO BE EXTREMELY LOOSE AND THE LV LEAD WAS MOVING THROUGH THE SUTURE SLEEVE. AN ATTEMPT TO REVISE THE LEAD WAS UNSUCCESSFUL, THUS THE LEAD WAS EXPLANTED AND THE LV PORT ON THE DEVICE WAS PLUGGED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25904 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 4555| 0185| 4135| N119