COGNIS
Models N106/N107/N118/N119/P106/P107
TELIGEN VR
Models E102/F102
TELIGEN DR
Models E110/F110
Voluntary Physician Advisory
FDA Classification: Class II
COGNIS CRT-Ds and TELIGEN ICDs include a Respiratory Sensor that can be activated to monitor the patient's respiratory rate. For any implantable defibrillator, delivery of appropriate therapy is dependent upon lead system integrity. Conversely, if any component of the defibrillator system is compromised, appropriate therapy cannot be assured. For example, certain RV lead complications can cause inappropriate shocks or anti-tachycardia pacing, and/or inhibition of pacing. Boston Scientific has determined that if such RV lead complications were to occur with the Respiratory Sensor programmed On, additional oversensing may occur, thereby increasing the probability of inappropriate therapy. Five to eight successive inappropriate shocks could leave the device unable to treat an actual arrhythmia until the current episode ends.
No patient deaths have been reported. Additional events can be prevented if recommendations are followed.
Reported Events and Rate of Occurrence
Boston Scientific estimates that the Respiratory Sensor has been programmed On in approximately 8,000 COGNIS and TELIGEN devices worldwide. Inappropriate therapy as described above has been reported 15 times (0.2%).
Programmer software is available which automatically programs Respiratory Sensor Off. When the Respiratory Sensor is Off, this advisory does not apply and routine follow-up is indicated.
Reported events (worldwide)
Twenty-six (26) reports of inappropriate therapy have been received from an estimated 12,500 COGNIS and TELIGEN devices in which the Respiratory Sensor has been programmed On.
One death has been reported where inappropriate shocks were delivered in conjunction with a fractured non-BSC lead. Although the Respiratory Sensor was ON, its contribution to the patient outcome cannot be determined.
Rate of Occurrence
For the estimated 12,500 devices which had the Respiratory Sensor programmed On worldwide, the rate of occurrence is 0.2%. Product Improvements have been implemented that will reduce the likelihood of future events. The Respiratory Sensor is Off in all new devices being shipped, and if a physician attempts to program the sensor On, there is a programmer software pop-up window to instruct users to check for noise when the Respiratory Sensor is turned On. In addition, recent improvements to the device header are designed to facilitate ease of lead connections to the device.
Patient management recommendations from the March 23, 2009 physician communication remain unchanged.
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.
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.
Standard Warranty program available, please contact your local representative for terms and conditions.
With respect to the number of reported events listed in the summaries above, Boston Scientific recognizes that the actual number of clinical malfunctions may be greater than the number actually reported. Additionally, rate projections are provided with the acknowledgement that predictive modeling is inherently uncertain due to its dependence on the device age distribution of reported events and resultant statistical approximation and assumptions.
Advisory notifications may vary by geography, based upon local regulatory requirements. Please contact the local Boston Scientific office for more information. Not all products may be approved for use in all geographies, as product approval is geography specific.
