If you either a Medtronic of Guidant device which you believe may be affected by recent product advisories, please click on the respective above links or more information

A perspective on device recalls

Do you know anyone who is perfect?  The correct answer to this question is, of course, no.  Since people - in fact large teams of people - design implantable devices, imperfect devices occur.  There have been product recalls and reported technical problems with implanted devices since the first pacemaker was implanted 50 years ago.  Some of the original failures of pacemakers involved leaking batteries.  These pacemakers would suddenly stop pacing without warning.  Other failures in earlier pacemaker models included sudden "runaway" pacing in which the pacemaker would start pacing the heart at rates of over 200 beats per minute (which can induce sudden death).  Device technical failures affect not only pacemakers and defibrillators but also pacing and defibrillation leads. Pacemaker leads (wires attaching the pacemaker to the heart)  have been corroding and fracturing since the first pacer lead was designed.  Earlier generations of pacemaker leads would fracture or short-out in up to a third of all patients.

In fact, every type of medical device ever made from artificial hips to breast implants to pacers/ICDs have failed.  Failures have occurred in the past with all of these products.  Failure in the future with subsequent generations of devices will also occur; these devices are too complex and technology changes too rapidly in this field to absolutely guarantee against all failures.  To do so would entail many additional years of testing for these devices while patient care suffered. For example, biventricular pacemakers (which help patients with congestive heart failure) were approved after about two years of testing.  If years of additional testing was mandated, hundreds of thousands of patients with heart failure would either be suffering or perhaps deceased by now.

In light of the above considerations, the best pacemaker companies can do is to test new devices as diligently as possible, to warrant devices and replace them for free should failure occur and, perhaps most importantly, to track implanted devices and, if appropriate, notify patients and physicians should a serious technical issue arise with an implanted device.  We do not mean to minimize the seriousness of this issue. Pacemaker manufacturers must do everything possible to minimize device failures and should be honest and forthright should a failure issue arise.  These companies are in the business of building machines that are made to save and extend peoples lives.  Thus, they need to held accountable for their products and absolutely must notify patients and implanting doctors about any and all issues which arise regarding their products reliability.  In this web site, we have information on the recent recalls for the Medtronic and Guidant devices.  If you have a Medtronic or Guidant device, click on the above links to find out if your device is affected and for further information.