COGNIS CRT-D and TELIGEN ICD Product Advisory

Boston Scientific issued a product advisory on March 23, 2009, indicating that inappropriate therapy associated with certain right ventricular (RV) lead complications may occur more frequently if the Respiratory Sensor is programmed On. TELIGEN ICD products, model numbers E102, E110, F102, F110 and COGNIS CRT-D products, model number N106, N107, N118, N119, P106, P107 are affected.

• Read the letter sent to physicians (PDF, 56K)
• Read the Physician Advisory Notice (PDF, 50K)

Boston Scientific has issued the following Patient Management Recommendations to eliminate incremental risks described in the advisory. Device programming records should be reviewed for each patient with a COGNIS CRT-D or TELIGEN ICD to determine if the Respiratory Sensor is programmed to On or Off.

• When the Respiratory Sensor is Off, this advisory does not apply and routine follow-up is indicated.
• If the Respiratory Sensor is On, Boston Scientific recommends that the Respiratory Sensor be programmed Off with the following steps:

1. Select the SETTINGS tab

2. Select the SETTINGS SUMMARY tab

3. In the BRADY section, select the NORMAL SETTINGS details icon

4. In the SENSORS AND TRENDING section, select the ACCELEROMETER details icon

5. For RESPIRATORY SENSOR, select Off, and press PROGRAM

Physicians should review concurrent risks such as pacemaker dependency, historic lead fracture performance, patient age and activity level, etc., when considering the most appropriate management options for each patient.

For more information, please contact Boston Scientific Cardiac Rhythm Management at 1 (800) 227-3422 or Tech.Services@bsci.com.