BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 2040092 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00530
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    G050163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED DEFORMED CONDUCTOR COILS, AN INDENTATION IN THE OUTER INSULATION, AND A TEAR IN THE INNER INSULATION. FRACTURED CONDUCTOR COILS WERE ALSO NOTED 428 MILLIMETERS (MM) FROM THE TERMINAL PIN. IT WAS NOTED THAT THE LEAD APPEARED TO HAVE BEEN POSSIBLY GRABBED WITH SOME TYPE OF TOOL. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS THE ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY OF THE LEAD. THE LEAD DID NOT PASS THE ELECTRICAL CONTINUITY TESTING. IT WAS NOTED DURING LABORATORY TESTING THAT THE DAMAGE TO THE LEAD APPEARED TO HAVE BEEN INDUCED SOMETIME DURING THE IMPLANT PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS LEFT VENTRICULAR (LV) LEAD, THE LEAD APPEARED TO BE FRACTURED OR OTHERWISE COMPROMISED AFTER THE PHYSICIAN SUTURED THE LEAD. PACING IMPEDANCES WERE NOTED TO BE GREATER THAN 2,500 OHMS AND THRESHOLDS WERE INCREASED. THE LEAD WAS SUBSEQUENTLY REMOVED AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS ALSO NOTED THAT THE LEAD WOULD BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE LEAD WAS LATER RETURNED FOR ANALYSIS.

    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 74 YR 4592| N119| 4470| 0184| 4543