BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 2780110 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12861
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 1, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REAMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITOINAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LATITUDE REPORTED MULTIPLE RED ALERTS FOR THIS SYSTEM WHICH INCLUDED ONE FOR PACING IMPEDANCES GREATER THAN 2000 OHMS FOR THIS LEFT VENTRICULAR (LV) LEAD. THIS PATIENT REPORTED RECEIVING A SHOCK WHEN HE STEPPED OUT OF HIS CAR ONTO AN EXPOSED WIRE ON THE GROUND. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE SUSPECTS IT WAS A COINCIDENCE THAT THE PATIENT STEPPED ON THE WIRE WHILE GETTING A SHOCK FROM THE DEVICE. SYSTEM EVALUATION NOTED NOISE ON THE LEADS DURING THE EPISODE. THEY WERE UNABLE TO RECREATE THE NOISE DURING ISOMETRICS AND POCKET MANIPULATION. THERE IS KINKING OF THE LEAD BODY AT THE INSERTION POINT INTO THE SUBCLAVIAN. THE LV LEAD CONFIGURATION WAS REPROGRAMMED LV TIP TO CAN WHICH PRODUCED NORMAL PACING IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4591

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening 4542| 0157| 4086| N119| 4591