Alerts and Recalls

As most of you are well aware, there have been a number of well publicized nationwide recalls involving pacemakers and defibrillators in the last several months.  We at the Heart Center of the Rockies, especially the Defibrillator and Pacemaker Clinic, would like to assure all of our patients that we are taking steps to ensure that all of our patients' devices are functioning appropriately and that patients are not at significant risk for adverse health consequences due to these recalls.  I would like to take you through a step-by-step summary of how we at the Heart Center of the Rockies deal with these recalls to ensure the highest quality care is provided to our patients.

Device recalls are initiated by the device companies, who send letters with a summary of the potential device problem.  Upon receiving these recall letters, we utilize our computerized database to identify patients with the affected devices. Our highly trained Device Clinic nurses and nurse practitioners then individually go through the clinical charateristics of each and every patient with an affected device.  In consultation with Dr. Johnson, we then determine whether the potential problem with the device could result in any serious adverse consequences for the individual patient.

All patients who have devices affected by the recall are notified in writing by Heart Center of the Rockies.  If it is felt that a patient is at significant risk for adverse health consequences due to the recall, we send a certified letter and ask that patient to come in for evaluation in a timely fashion.  The majority of device recalls do not pose high risk for serious adverse consequences, and, in this case, we simply follow the device on a routine basis.

If after further device evaluation it is determined that there is a significant risk of adverse health consequences, then counseling sessions with the patient are arranged.  This will usually involve a meeting with the Device Clinic specialists, as well as either Dr. Johnson or the patients' personal cardiologist.  At this time the potential risks involved with the recall are outlined, and a strategy to determine the best course of action is decided upon.  Often this may involve simple reprogramming of the pacemaker or defribrillator device, which can be easily accomplished here in the office.  In rare cases, replacement of the affected device may be recommended.

As always, we at the Heart Center of the Rockies take our commitment to providing excellent care to our patients as paramount.  We therefore carefully analyze each and every individual case to determine the risk of adverse health outcomes associated with a device recall versus the risk of simply following the device, making reprogramming changes in the office, or exchanging/replacing the device via surgery.

As FDA rules and regulations regarding implanted devices undoubtedly will become more strict in the near future, you as patients of Heart Center of the Rockies can rest assured that we are taking every step to protect your health and will continue to provide you with the highest quality, well informed, comprehensive care that you are accustomed to.  If you have any questions regarding your individual device or any of the recent device recalls, please contact one of our Device Clinic specialists at Heart Center of the Rockies, 970-221-1000.