BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1952775 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-24506
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATIONS INDICATED A COMPLETE LEAD WAS RETURNED. THERE WAS DRIED BLOOD/BODY FLUID NOTED IN THE LEAD LUMEN. A CONTINUITY TEST WAS PERFORMED WITH MANIPULATION AND THIS LV LEAD PASSED. THE INITIAL ALLEGATIONS OF HIGH THRESHOLDS AND DISLODGEMENT COULD NOT BE CONFIRMED DURING TESTING. ELECTRONICALLY, LV LEAD WAS FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITING HIGH THRESHOLDS AND A DISLODGMENT WAS SUSPECTED DURING AN ABLATION PROCEDURE. A REVISION PROCEEDURE WAS PERFORMED WHICH FOUND THE LV LEAD WAS PULLED BACK AND FELL INTO THE CORONARY SINUS. THE LV LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4591

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention H120| 4542| 4470| 4137| 4591