BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2173365 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11202
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    July 7, 2010
    Report Date
    June 13, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS ABANDONED, THEREFORE BOSTON SCIENTIFIC CRM WILL BE UNABLE TO PERFORM ANALYSIS ON THIS LEAD. SHOULD IT BE RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. IT WAS SUSPECTED TO BE A RESULT OF A LOOSE SETSCREW. THE LEAD WAS RESEATED AND THE IMPEDANCE MEASUREMENTS RESOLVED. INFORMATION WAS LATER REPORTED THAT THE LEAD WAS SURGICALLY ABANDONED DUE TO LOSS OF CAPTURE AND HIGH THRESHOLD MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 4555| 0158| 4470| 4592| N119