BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 2905462 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-14128
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTD
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE LOCAL FIELD REPRESENTATIVE THAT THE PHYSICIAN WILL CONTINUE TO MONITOR THE ADAPTER AND LV LEAD. 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

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS ADAPTER AND ANOTHER MANUFACTURER'S LEFT VENTRICULAR (LV) LEAD, EXPERIENCED A HEART FAILURE EVENT AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. IT WAS REPORTED THAT THE LV LEAD EXHIBITED LOSS OF CAPTURE (LOC) WITH THE PATIENT LAYING ON THEIR RIGHT SIDE AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS IN ALL POSITIONS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) THAT THERE WERE NO AVAILABLE PROGRAMMING OPTIONS AND DISCUSSED PERFORMING A LEAD REVISION PROCEDURE DUE TO THE POSITIONAL LOC. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10594 UNKNOWN LEAD ADAPTER DTD CPI - DEL CARIBE 6744

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L 6744| 2187| 0158| N118| H115| H215| 5076