BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2050261 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-02976
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 16, 2011
    Report Date
    June 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. DRIED BLOOD WAS NOTED THROUGHOUT THE LEAD'S LUMEN AT THE TIP AREA WHICH MAY HAVE CONTRIBUTED TO THE REPORTED CLINICAL ALLEGATION. ELECTRICALLY, THIS LEAD MET SPECIFICATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS LEFT VENTRICULAR LEAD DISPLAYED INCREASED THRESHOLD AND IMPEDANCE MEASUREMENTS. A CHEST X-RAY WAS PERFORMED REVEALING THIS LEAD HAD DISLODGED. A REVISION PROCEDURE WILL BE SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WITH THIS LEFT VENTRICULAR LEAD EXPERIENCED DIAPHRAGMATIC STIMULATION AND WAS PROGRAMMED OFF. A REPLACEMENT PROCEDURE WAS PERFORMED. THIS LEAD COULD NOT BE REPOSITIONED AS A STABLE POSITION COULD NOT BE OBTAINED. THIS LEAD WAS REMOVED.

    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 69 YR Required Intervention N107| 4087| 0185| 4592