BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2042365 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02630
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    March 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P050046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, OR IF THE LEAD IS RETURNED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION NOTED SEVERAL COMPRESSIONS IN THE COILS AND A CUT IN THE LEAD INSULATION. RESISTANCE TESTING AND A PRESSURE TEST OF THE INNER INSULATION WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. A PRESSURE TEST OF THE OUTER INSULATION WAS PERFORMED AND THE DEVICE DID NOT PASS AT THE COMPRESSED LOCATIONS. LABORATORY ANALYSIS DID NOT CONFIRM THE CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A COMPETITOR LEAD REVISION PROCEDURE, THIS IMPLANTABLE LEFT VENTRICULAR (LV) LEAD HAD INADVERTENTLY DISLODGED. THE LEAD WAS UNABLE TO BE REPOSITIONED AND A REPLACEMENT LV LEAD WAS SUCCESSFULLY IMPLANTED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R 4543| MISMATCH| 4470| 4555| 4592| H220