BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 3052663 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04070
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE WHEN CONNECTING THE LEFT VENTRICULAR LEAD TO THE DEVICE HIGH OUT OF RANGE PACING IMPEDANCES WERE NOTED. THE LEAD WAS RE-TESTED WITH THE PACING SYSTEM ANALYZER (PSA) AND OUT OF RANGE PACING IMPEDANCES WERE ONCE AGAIN NOTED. THE PHYSICIAN SUSPECTED THERE WAS A BREAK IN THE INSULATION DUE TO THE PHYSICIAN POSSIBLY NICKING THE LEAD DURING PLACEMENT. THE PATIENT WAS NOT STABLE TO HAVE THE LEFT VENTRICULAR LEAD EXPLANTED OR IMPLANTING A NEW LEAD THUS THE DEVICE WAS PROGRAMMED TO LV TIP TO RV RING CONFIGURATION AND LEFT IMPLANTED WITH NORMAL PACING IMPEDANCES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155401 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4554

    Patients

    Seq Age Sex Outcome Treatment
    1