BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2173148 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10412
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 5, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. 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

    ADDITIONAL INFORMATION RECEIVED FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED THE LV LEAD WAS EXPLANTED DURING A DEVICE CHANGEOUT PROCEDURE. IT WAS REPORTED THE LEAD HAD A CONDUCTOR FRACTURE. IT WAS DISCARDED BY THE HOSPITAL STAFF AND WILL NOT BE RETURNED 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS. THE PATIENT WAS PACEMAKER DEPENDENT AND LV CAPTURE WAS UNABLE TO BE OBTAINED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4554

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R H120| 4554| 4087| 4086