BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3050028 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03520
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 26, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. IT WAS DETERMINED THAT THE LEAD HAD BEEN PROGRAMMED TO TRIAD CONFIGURATION. ONCE PROGRAMMED, DFT TESTING REVEALED NORMAL SHOCK IMPEDANCE MEASUREMENTS. THIS DEVICE AND LEAD REMAIN IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST IMPLANT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. AN INTERNAL TECHNICAL SERVICE (TS) CONSULTANT WAS CONTACTED FOR THEIR RECOMMENDATIONS. REPORTEDLY, DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED, HOWEVER, THE RESULTS WERE NOT AVAILABLE AS OF THIS TIME. FURTHER SYSTEM INTEGRITY WAS RECOMMENDED. AS OF THIS TIME, THIS LEAD AND DEVICE REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153188 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R