BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2913091 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00410
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    June 8, 2012
    Report Date
    January 15, 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

    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 A ROUTINE DEVICE CHANGE OUT PROCEDURE, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ((B)(4)) WAS CONNECTED TO THE EXISTING LEADS. UPON LEAD INTEGRITY TESTING THE RIGHT VENTRICULAR (RV) LEAD REVEALED HIGH SHOCK IMPEDANCES GREATER THAN 125 OHMS AND HIGH THRESHOLD MEASUREMENTS. THE VENTRICULAR LEAD WAS DISCONNECTED AND THE DEVICE WAS REMOVED FROM THE POCKET AND THE PORTS WERE FLUSHED AND THE CONNECTOR PINS WERE CLEANED. THE DEVICE WAS THEN REINSERTED INTO THE POCKET, THE VENTRICULAR LEAD CONNECTED INTO THE DEVICE FOR FURTHER TESTING. THE SHOCK LEAD MEASUREMENTS REMAINED THE SAME GREATER THAN 125 OHMS. FLUOROSCOPY WAS CARRIED OUT TO ASSESS THE VENTRICULAR LEAD AND NO ABNORMALITIES WERE FOUND. AGAIN, TO DETERMINE IF THIS WAS A LEAD OR DEVICE ISSUE THE LEAD WAS THEN DISCONNECTED FROM THE NEW DEVICE AND THE OLD DEVICE WAS CONNECTED TO THE VENTRICULAR LEAD. THE OLD DEVICE AND LEAD WERE TESTED AND SHOCK IMPEDANCES WERE WITHIN NORMAL RANGE. A DEVICE ISSUE WAS SUSPECTED AND THE DECISION WAS MADE TO REMOVE AND REPLACE THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT REVIEWED A DATA DISK AND REVIEWED THE MEMORY OF THIS DEVICE. AFTER REVIEW TS CONCLUDED THAT IN THE EVENT THAT THE PROXIMAL COIL CONNECTION WAS INCOMPLETE DURING THE DEVICE E CHANGE OUT OR LEAD INTEGRITY WAS COMPROMISED, I.E. FRACTURE, THE SHOCK IMPEDANCE WOULD BE >125 OHMS FOR ANY CONFIGURATION INVOLVING THE PROXIMAL COIL. DUE TO THE DEVICE CHANGE OUT, THERE IS ALWAYS A RISK OF AN UNDERLYING LEAD ISSUE THAT MAY NOT BE EVIDENT UNTIL AFTER THE DEVICE REPLACEMENT AS A RESULT OF NORMAL MANIPULATION OF THE LEAD SYSTEM OR THE POSSIBILITY OF INDUCED DAMAGE WHICH IS WHY OUR LABELING SUGGESTS LEAD TESTING IS RECOMMENDED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20803 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F141

    Patients

    Seq Age Sex Outcome Treatment
    1