Device Programming Scam

I saw a case the other day that really disturbed me.

At first it seemed innocuous enough: a three-year old defibrillator whose battery was at end-of-life. But the battery voltage was unusually low: 1.59 volts. The elective replacement indicator (or “ERI,” as we call it) for this device was 2.51 volts.

Sometimes when battery voltages get real low, the devices don’t behave properly, so we elected to admit the patient and prep him/her (sex change for confidentiality reasons – you decide which gender you prefer to place in the sentence) for a battery change procedure.

While in the Electrophysiology Laboratory in a controlled setting, we checked the device, and were shocked to note that one of the leads was pacing at the maximum output of the device, but the pacing thresholds (the minimum voltage required to pace the heart) were much better than those settings. If the device had had its voltage dropped appropriately, battery voltage (and device longevity) could have been greatly preserved. The patient reassured me that he/she had been checked every three months while visiting another (undisclosed) state.

Now the potential explanations for this could be many: the person programming the device forgot to reset the lead voltage back to its appropriate setting, the threshold of the suspect lead actually DID improve (seems unlikely), the person programming the device wasn’t aware of the proper pacing threshold and wanted to “assure pacing,” or possibly as one of our local reps suggested (I hoped this was not the case), the doctor increased the voltage on the lead to burn out the battery faster so a new procedure would be needed sooner.

“Have you heard of this happening?” I asked the rep, who spoke on the condition of anonymity. After all, scores of engineers have worked tirelessly to develop algorithms (like St. Jude's Autocapture, or Medtronic's Capture Management and Search AV features) to preserve battery life and promote device longevity.

“Well, I’ve seen it. Usually not as dramatic as this, but voltages are increased to ‘assure safety’ but really they’re also interested in procedures,” he/she said.

Geez. How does one prove this if it is happening? There’s plenty of cover here: device reps often help busy doctors reprogram pacemakers (Device companies: can you say liability?). This leads to the “Gee, I didn’t know” syndrome to deflect liability. Could this be done “in the best interest of the patient” to assure pacing in those who are pacemaker-dependent for their hearts to beat? (Sounds noble, doesn’t it?) There seems to be no easy way to catch slimy physicians who might be involved in such a scheme. Patients need to be aware this could be happening and stay informed how their devices are programmed: ask for a copy of the interrogation of your device, my friends.

Fortunately, it appears that the FDA might have a way to thwart such behavior. There is a push at the FDA to develop powerful databases to monitor characteristics of implantable devices after they are approved to the public via large databases. Most of this is to assure product safety and reliability. But trends can be identified regarding implanters, as well. Scumbag physicians beware.

Additionally, the development of newer internet-capable medical devices that relay their programming information to a centralized database will permit the monitoring of trends to avoid such a programming “mistake” for patients, but doctors involved in the management of these patients need to remain vigilant for this potential scam.

-Wes