BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2042404 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01228
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 31, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE LEAD HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    OUR POST MARKET QUALITY ASSURANCE LABORATORY CANNOT CONFIRM THE DISLODGEMENT ALLEGATION. HOWEVER, EVIDENCE AND PAST EXPERIENCE SUGGESTS THAT LEAD DISLODGEMENT CAN BE THE RESULT OF UNIQUE PATIENT PHYSIOLOGY AND/OR IMPLANT TECHNIQUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE LV LEAD WAS EXPLANTED AND REPLACED WITHOUT COMPLICATION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED FOR RELIABILITY ANALYSIS.

    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 73 YR Hospitalization 4542| 4087| 1194| 4591| 0181| 4458| N119