BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3052557 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04278
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    November 18, 2011
    Report Date
    February 26, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. 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 DURING AN IMPLANT PROCEDURE OF THE RIGHT VENTRICULAR (RV) LEAD HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS WERE OBTAINED. THE LEAD WAS DISCONNECTED AND RECONNECTED TO THIS DEVICE WITHOUT OBTAINING A BETTER IMPEDANCE MEASUREMENT. THE POCKET WAS CLEANED AND SHOCK IMPEDANCE MEASUREMENTS WERE TAKEN AGAIN WITH MEASUREMENTS WITHIN RANGE. IT WAS DECIDED TO TAKE MEASUREMENTS AGAIN WITHIN THE NEXT COUPLE OF DAYS TO DETERMINE THE SHOCK IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT SHOCK IMPEDANCE MEASUREMENTS WERE TAKEN AGAIN AFTER SEVERAL DAYS AND ALL MEASUREMENTS WERE WITHIN ACCEPTABLE PARAMETERS. THERE WERE NO CHANGES MADE TO THE LEAD OR THIS DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155059 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND P142

    Patients

    Seq Age Sex Outcome Treatment
    1 0295| 4549| P142| 4096