BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3041107 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02171
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    November 14, 2012
    Report Date
    May 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN WILL CONTINUE MONITORING. 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

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN WILL CONTINUE TO MONITOR THE DEVICE/LEAD SYSTEM. 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

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THREE MONTHS LATER THAT THE DEVICE AND RIGHT ATRIAL (RA) LEAD CONTINUE TO EXHIBIT HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. ADDITIONALLY, THE RA LEAD EXHIBITED LOSS OF CAPTURE (LOC), HOWEVER, IT WAS REPORTED THAT THE PATIENT IS NOT ATRIALLY PACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IN-CLINIC FOLLOW UP, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. IT WAS REPORTED THAT DEVICE MEMORY REVEALED THE HIGH OUT OF RANGE MEASUREMENTS BEGAN APPROXIMATELY TWO MONTHS AGO. THE RIGHT ATRIAL (RA) LEAD ALSO EXHIBITED NOISE AND OVERSENSING RESULTING IN INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) MODE SWITCHES. ADDITIONALLY, NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD THAT WAS FELT TO BE OVERSENSING OF SENSED ATRIAL ACTIVITY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142966 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N140

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR 4473| MISMATCH| N140| 4474| 1270| 0295