BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3210988 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08698
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE REMAINS 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 THIS PHYSICIAN CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT THIS PATIENT SUFFERED A CARDIAC ARREST AND THE DEVICE DID NOT PROVIDE THERAPY. IT WAS UNCLEAR IF THE PATIENT EXPERIENCED A CARDIAC OR RESPIRATORY ARREST. EMERGENCY MEDICAL SERVICES (EMS) HAD BEEN CONTACTED AND THE PATIENT WAS INTUBATED. AN AUTOMATIC EXTERNAL ICD WAS APPLIED; HOWEVER, THE PATIENT DID NOT HAVE A RHYTHM THAT NECESSITATED A SHOCK. THE PATIENT WAS ADMITTED TO THE HOSPITAL BUT HAS SINCE BEEN DISCHARGED. TS SUGGESTED THAT THE PATIENT BE SCHEDULED FOR AN IN-CLINIC INTERROGATION OF THE DEVICE. THE PATIENT HAS BEEN ENROLLED FOR A PATIENT MONITORING SYSTEM BUT THE SYSTEM IS NOT CURRENTLY ACTIVE. ACCORDING TO THE DEVICE-FOLLOWING PHYSICIAN, THE PATIENT HAS NOT BEEN SEEN IN-CLINIC FOR OVER ONE YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310602 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E140

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L 0276| E140