BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 4131445 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14273
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    May 13, 2015
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    OJX
    PMA / PMN Number
    P050046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

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    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM A JOURNAL ARTICLE RECEIVED INDICATES THAT THE PATIENT IS A (B)(6)MALE WHO HAD BEEN IMPLANTED WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODEL P108 AND LEAD SYSTEM WHICH INCLUDED THIS LEFT VENTRICULAR (LV) LEAD MODEL 4555 IN (B)(6) 2011 FOR SYMPTOMATIC (NYHA CLASS 3) ISCHEMIC CARDIOMYOPATHY AND CHRONIC ATRIAL FIBRILLATION (AF). DURING THE IMPLANT PROCEDURE, THE LV LEAD WAS PLACED IN A LARGE LATERAL CORONARY VEIN. ONE MONTH LATER, THE LV LEAD WAS FOUND DISPLACED AT THE CORONARY VENOUS OSTIUM BUT STILL CAPTURED THE MYOCARDIUM WITH LOW THRESHOLD (1 V). IN (B)(6) 2012, THE PATIENT WAS RE-HOSPITALIZED FOR HEART FAILURE. PERCENTAGE OF STIMULATION WAS LESS THAN 70% DUE TO AF WITH A RAPID VENTRICULAR RATE. AV JUNCTION ABLATION WAS PERFORMED AND THE DEVICE WAS PROGRAMMED TO VVI 80. IN (B)(4) 2012, REMOTE MONITORING OF THE DEVICE REVEALED 99% OF RV PACING AND 58% OF LV PACING. ELECTROGRAM (EGM) ANALYSIS, NOTED INTERMITTENT DETECTION OF ATRIAL FAR-FIELD ACTIVITY LEADING TO INHIBITION OF LV PACING. THE PATIENT WAS CONTACTED AND LV DETECTION WAS PROGRAMMED OFF. SINCE THAT TIME, THE PATIENT REMAINED IN NYHA CLASS 2 AND REMOTE MONITORING CONFIRMED STABLE 99% OF BIVENTRICULAR PACING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS UNKNOWN LEFT VENTRICULAR (LV) LEAD DISLODGED CAUSING OVERSENSING OF PATIENT'S ATRIAL FIBRILLATION ON THE LV CHANNEL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. LEAD STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611795 ACUITY IMPLANTABLE LEAD OJX GUIDANT PUERTO RICO BV 4555

    Patients

    Seq Age Sex Outcome Treatment
    1