BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 4882811 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-06172
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    January 1, 2015
    Report Date
    March 24, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED MULTIPLE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. THE CAUSE OF THE ISSUE HAS NOT BEEN DETERMINED AND NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WILL CONTINUE TO BE MONITORED AND THE DEVICE CONTINUES TO REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED FROM THE FIELD INDICATES THE PATIENT WAS LATER SEEN BACK IN THE CLINIC WHERE ONE 31 JOULE COMMANDED SHOCK WAS DELIVERED TO TEST THE SYSTEM INTEGRITY. THE SHOCK WAS SUCCESSFUL AT CONVERTING THE PATIENT AND THE SYSTEM REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427117 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E141

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R T175| E141