BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3052532 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03891
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    November 14, 2012
    Report Date
    March 4, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    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 FOLLOW UP VISIT, THIS DEVICE AND RIGHT VENTRICULAR LEAD DISPLAYED INCREASED IMPEDANCE MEASUREMENTS THAT HAD INCREASED GREATER THAN FIVE HUNDRED OHMS SINCE THE LAST MEASUREMENT. IN ADDITION, NOISE WAS NOTED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED FOR THEIR RECOMMENDATIONS AND AFTER REVIEWING THE DATA RECOMMENDED PROVOCATIVE LEAD TESTING. THE PATIENT WAS HOSPITALIZED AFTER RECEIVING AN INAPPROPRIATE SHOCK AND A SIMILAR INCREASED IMPEDANCE MEASUREMENTS OF THE LEFT VENTRICULAR LEAD. FURTHER REVIEW OF THE DATA REVEALED THE MEASUREMENTS HAD INCREASED AFTER THE PATIENT WITH THIS LEAD HAD EXPERIENCED A FALL. FLUOROSCOPY DID NOT REVEAL ANY LEAD OR CONNECTION ISSUES. DURING THE RETESTING, NORMAL MEASUREMENTS WERE OBTAINED. ALL MEASUREMENTS HAVE REMAINED NORMAL. A DECISION WAS MADE TO FURTHER MONITORING THIS SYSTEM AND NOT PERFORM INVASIVE TESTING. THE PATIENT WAS DISCHARGED HOME. UPON FURTHER TS ADVICE, THE DEVICE WAS REPROGRAMMED FROM EXTENDED BIPOLAR TO UNIPOLAR SETTINGS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154928 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND P143

    Patients

    Seq Age Sex Outcome Treatment
    1