BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2042268 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01370
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    April 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    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

    ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    Additional Manufacturer Narrative · 1

    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE COMPLETE LEAD WAS RETURNED WITH DRIED BODY FLUID IN THE LEAD LUMEN. ELECTROCAUTERY DAMAGED WAS NOTED IN SEVERAL PLACES IN THE LEAD INSULATION. FURTHER TESTING CONFIRMED THE LEAD TO BE ELECTRICALLY CONTINUOUS. NO FURTHER TESTING WAS PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LOSS OF CAPTURE (LOC) WAS OBSERVED ON THIS LEFT VENTRICULAR (LV) LEAD. ADDITIONALLY, INTERMITTENT LOC, WITH INCREASED THRESHOLD MEASUREMENTS WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. ALSO, DECREASED IMPEDANCE MEASUREMENTS WERE OBSERVED ON THE RV LEAD, ALTHOUGH REMAINING WITHIN ACCEPTABLE LIMITS. AN RV LEAD INSULATION BREAK WAS SUSPECTED. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND BOTH LEADS WERE EXPLANTED AND REPLACED. NO FURTHER COMPLICATIONS WERE OBSERVED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION IN (B)(6) 2011 THAT THE PATIENT HAS RETAINED AN ATTORNEY AND RECENTLY SUBMITTED PAPERWORK AS PART OF THE LITIGATION PROCESS.

    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 52 YR Hospitalization| R H120| 4055| 4473| 4054| 4591