BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3930010 · Received July 11, 2014

    Report

    Report Number
    2124215-2014-13756
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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) AND RIGHT VENTRICULAR (RV) EXHIBITED HIGH PACING IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS AND HIGH PACING THRESHOLD DURING PRE-DISCHARGE CHECK. SUBSEQUENTLY, THE FIELD REPRESENTATIVE SUGGESTED REPOSITIONING THE LEAD IF THE PACING THRESHOLD AND IMPEDANCE MEASUREMENTS ARE STILL HIGH. X-RAY WAS PERFORMED AND THE TERMINAL PIN COULD NOT BE SEEN BUT POSITION OF THE LEAD WAS STILL THE SAME. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT'S DEVICE WAS RE-EVALUATED AND THE PHYSICIAN OPTED TO MONITOR THE PATIENT. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407521 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E142

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR 4472| 0295| E142