BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3053571 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05279
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 28, 2013
    Report Date
    June 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABANDONED COMPETITOR LEAD AND DEVICE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC THEREFORE, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. 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

    AT THIS TIME, THE DEVICE AND COMPETITOR LEAD REMAIN IN SERVICE. A FINAL REPORT WILL BE SENT AFTER INFORMATION IS RECEIVED OF THE REVISION PROCEDURE. IF THE PRODUCT IS RETURNED TO BOSTON SCIENTIFIC LABORATORY ANALYSIS WILL BE PERFORMED TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY ONE DAY LATER, A REVISION PROCEDURE WAS PERFORMED DUE TO A SUSPECTED COMPETITOR LEAD ISSUE AS THE DEVICE AND LEAD REVEALED A RISE IN SHOCK IMPEDANCES GREATER THAN 200 OHMS. THE DECISION WAS MADE TO ABANDONED THE DEFIBRILLATION PORTION OF THIS LEAD AND A NEW DEFIBRILLATION LEAD WAS IMPLANTED. ALL MEASUREMENTS ARE NOW STABLE. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP VISIT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REVEALED A RISE IN SHOCK IMPEDANCE GREATER THAN 200 OHMS. AT THIS TIME THE DEVICE IS CONNECTED TO A COMPETITOR LEAD. THE DECISION WAS MADE TO ADMIT THE PATIENT TO THE HOSPITAL TO WAIT FOR A REVISION PROCEDURE IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155038 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F143

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R