BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3905418 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10972
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EMITTING TONES. THE PATIENT WAS EVALUATED IN THE CLINIC AND THE DEVICE WAS INTERROGATED AND REVEALED INTERMITTENT OUT OF RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. DURING THE FOLLOW-UP THE MEASUREMENTS WERE 912 OHMS. THE PHYSICIAN PLANNED TO CONTINUE TO FOLLOW THIS PATIENT. NO OTHER LEAD OBSERVATIONS WERE REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THIS PATIENT WAS NOT PACEMAKER DEPENDENT. THIS PRODUCT REMAINS IN-SERVICE. THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD IS A COMPETITOR'S PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383130 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F143

    Patients

    Seq Age Sex Outcome Treatment
    1 5554| 6948| F143