BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2910110 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15093
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    August 18, 2011
    Report Date
    April 7, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P050046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 LEFT VENTRICULAR (LV) LEAD EXHIBITED NOISE, HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS, AND SHOCK IMPEDANCE MEASURMENTS GREATER THAN 125 OHMS. A TECHNICAL SERVICE (TS) CONSULTANT WAS CONTACTED REGARDING THIS ISSUE AND INDICATED THAT THE LV LEAD IS PROGRAMMED TIP TO RV; THEREFORE, THE LEAD IS ELECTRICALLY TIED TO THE RV LEAD. THE DEVICE WAS PROGRAMMED TO MONITOR ONLY UNTIL A LEAD REVISION PROCEDURE CAN BE PERFORMED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE PATIENT WAS SEEN FOR A REVISION PROCEDURE. THE LEAD WAS SURGICALLY ABANDONED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19018 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4554

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R 4136| N119| 0158| 4554| 4592