Electromagnetic interference on cardiac pacemakers and implantable cardioverter defibrillators during endoscopy as reported to the US Federal Drug Administration

More than 3 million patients have a cardiac implanted electronic device (CIED) such as a pacemaker or implanted cardioverter-defibrillator in the USA. These devices are susceptible to electromagnetic interference (EMI) leading to malfunction and injury. Radiofrequency energy, the most common modality for obtaining hemostasis during endoscopy, is the most common source of EMI. Few studies have evaluated the effect of endoscopic radiofrequency energy on CIEDs. We aim to characterize CIED dysfunction related to endoscopic procedures. We hypothesize that EMI from endoscopic energy can result in patient injury. We queried the Manufacturer and User Facility Device Experience (MAUDE) database for CIED dysfunction related to electrosurgical devices over a 10-year period (2009–2019). CIED dysfunction events were identified using seven problem codes (malfunction, electromagnetic interference, ambient noise, pacing problem, over-sensing, inappropriate shock, defibrillation). These were cross-referenced for the terms “cautery, electrocautery, endoscopy, esophagus, colonoscopy, colon, esophagoscopy, and esophagogastroduodenoscopy.” Reports were individually reviewed to confirm and characterize CIED malfunction due to an endoscopic procedure. A search for CIED dysfunction resulted in 43,759 reports. Three hundred and eleven reports (0.7%) were associated with electrocautery, and of these, 45 reports (14.5%) included endoscopy. Ten reports involving endoscopy (22%) specified upper (3, 7%) or lower (7, 16%) endoscopy while the remainder were non-specific. Twenty-six of reports involving endoscopy (58%) suffered injury because of CIED dysfunction: Of these, 17 (65%) received inappropriate shocks, 5 (19%) had pacing inhibition with bradycardia or asystole, 3 (12%) had CIED damage requiring explant and replacement, and 1 (4%) patient suffered ventricular tachycardia requiring hospital admission. The use of energy during endoscopy can cause dysfunction of CIEDs. This most commonly results in inappropriate defibrillation, symptomatic bradycardia, and asystole. Patients with CIEDs undergoing endoscopy should undergo pre- and post-procedure device interrogation and re-programming to avoid patient injury.