BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2283172 · Received October 7, 2011

    Report

    Report Number
    2124215-2011-16276
    Event Type
    Injury
    Date Received
    October 7, 2011
    Date of Event
    March 17, 2011
    Report Date
    August 31, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD WAS PERFORMED. INSPECTION OF THE LEAD BODY, NOTED DEFORMED CONDUCTOR COILS AT 162, 165 AND 174 MM FROM THE TERMINAL PIN. LABORATORY TESTING DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE RESULTED IN THE CLINICAL OBSERVATION OF DISLODGEMENT. ELECTRICALLY, LEAD WAS FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS LEFT VENTRICULAR (LV) LEAD WAS PRESENTED FOR A CARDIOVERSION FOR ATRIAL FIBRILLATION. A SUCCESSFUL CARDIOVERSION WAS PERFORMED, HOWEVER, LOSS OF CAPTURE WAS OBSERVED IN ALL CONFIGURATIONS. THE LV LEAD WAS PROGRAMMED OFF. THE PHYSICIAN WAS TO CONFIRM POSITIONING WITH A PORTABLE CHEST XRAY. IT WAS LATER OBSERVED, THAT THE LV LEAD HAD DISLODGED. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE LV LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4554

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R 4554| 0157| 4086| N119