BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1864232 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16078
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 28, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE COMPLETE LEAD WAS RETURNED. BLOOD AND BODILY FLUIDS HAD INFILTRATED THE LEAD'S LUMEN. THE LEAD DID NOT PASS THE GUIDEWIRE INSERTION TEST MOST LIKELY DUE TO THE BLOOD AND BODY FLUID INFILTRATION. THE LEAD PASSED RESISTANCE AND PRESSURE TESTING VERIFYING THE LEAD'S ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. THE ALLEGATION OF LEAD DISLODGEMENT WAS NOT CONFIRMED IN ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD DISLODGED ONE MONTH POST IMPLANT. THE LEAD WAS EXPLANTED AND THE PHYSICIAN ELECTED TO IMPLANT A NEW LEAD IN A DIFFERENT TARGET VESSEL. THERE WERE 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 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention T175| 0158| 4555| 4087| H217| T135| 4554