BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3053202 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05048
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LATITUDE DATE BY TECHNICAL SERVICES NOTED THAT SEVERAL EPISODES WERE TRIGGERED BY MYOPOTENTIAL OVERSENSING, AND THE LONGEST VENTRICULAR PAUSE DUE TO PACING INHIBITION WAS > 2 SECONDS. TECHNICAL SERVICES DISCUSSED THAT MYOPOTENTIAL OVERSENSING IS LIKELY CAUSED BY DIAPHRAGMATIC/ABDOMINAL MUSCLE CONTRACTIONS. TECHNICAL SERVICES ALSO DISCUSSED PROGRAMMING OPTIONS. FOR MORE DETAILED ANALYSIS DATA DISK WAS REQUESTED IF POSSIBLE TO OBTAIN. AT THIS TIME THE SYSTEM REMAINS IMPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NOISE AND PACING INHIBITION WAS NOTE WHEN REVIEWING THE PATIENT LATITUDE DATA. DURING A FOLLOW UP MANIPULATION OF THE PECTORAL AND ABDOMINAL CONTRACTIONS TO TRY AND RECREATE THE NOISE SEEN ON THE RIGHT VENTRICULAR LEAD WAS NOT SUCCESSFUL, HOWEVER, DEEP INHALATION DID IN FACT CAUSE THE EXACT NOISE SEEN IN THE EPISODES FLAGGED UP FROM THE LATITUDE SYSTEM. ALL MEASUREMENTS WERE WITHIN NORMAL VALUES. DUE TO THE FACT THAT ON ONE EPISODE NOISE DID INHIBITION PACING THE RIGHT VENTRICULAR SENSITIVITY WAS REPROGRAMMED AS A PRECAUTIONARY MEASURE. A REQUEST FOR FURTHER OPTIMIZATION WAS SENT TECHNICAL SERVICES. TECHNICAL SERVICES DISCUSSED NOISE AND PROGRAMMING OPTIONS. FURTHER INFORMATION PROVIDED NOTED THAT THE RIGHT VENTRICULAR LEAD IMPLANTED HAS PREVIOUSLY BEEN REPORTED TO HAVE PROVIDED INAPPROPRIATE SHOCK FOLLOWING PACING INHIBITION DUE TO NOISE WHEN IMPLANTED WITH ANOTHER DEVICE. THE OLD DEVICE WAS REPROGRAMMED AND NO FURTHER ISSUES WERE NOTED UNTIL RECENTLY WITH THE NEW DEVICE AND PREVIOUSLY IMPLANTED RIGHT VENTRICULAR LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155320 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND P143

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening