MAUDE Database Review of Upper Airway Stimulation Sensor Lead Migration

Introduction: To date, there is one published case series on explantation of the Inspire upper airway stimulation (UAS) device; a device to treat obstructive sleep apnea. Unilateral hypoglossal nerve stimulation involves surgical implantation of a pulse generator, respiratory sensing lead, and stimulation lead. Complications may arise related to all components. With a growing number of implanted patients, the opportunity exists to pool collective experience for rare outcomes such as explantation/repositioning in order to better inform patients and providers.

Methods: We queried FDA's Manufacturer and User Facility Device Experience (MAUDE) database for events related to respiratory sensor for Inspire device (code MNQ) for events from January 1, 2000 - December 1, 2022. Primary outcomes were respiratory lead migration resulting in pneumothorax or need for revision surgery/explanation. We determined frequency of these adverse events over time. This exploratory query was aimed at investigating frequency and patterns using descriptive statistics.

Results: 765 events related to Inspire UAS were identified. 151 were reported as related to the respiratory sensing lead, and of those, 62 were related to lead migration. Excluding events where the lead tip separated from the lead body, there were 5 events related to migration of the entire distal sensing lead into the pleural space. All of these cases underwent revision surgery. These represented < 1% of adverse events reported related to UAS. Only one case specifically noted a pneumothorax due to respiratory sensing lead migration. Two cases of respiratory sensor migration requiring revision surgery from our institution are discussed in detail. Special considerations including involvement of thoracic surgery and chest tube placement are discussed.

Conclusions: Migration of respiratory sense lead is a rare event with multidisciplinary surgical planning considerations.