A Review of Reported Adverse Events in MRI-Safe and MRI-Conditional Cochlear Implants.

OBJECTIVES: This study looks to examine how the development of diametric magnet cochlear implant devices (CIDs) has affected observed magnetic resonance imaging (MRI)-related adverse events and MRI safety measures. METHODS: A search of the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was conducted using the product code "MCM" for "Cochlear implants." Reports were included for analysis if they involved MRI in recipients of cochlear implantation. Included reports were stratified into two cohorts by year: 2010 to 2014 and 2015 to 2020, reflecting the FDA approval of diametric magnet cochlear implants in 2015. Extracted event variables included implant manufacturer, adherence to MRI protocol, patient injuries, and device malfunctions. RESULTS: The product code search query yielded a total of 27,305 reports, from which 584 reports were included for analysis. From 2010 to 2014, there were 109 adverse events and 30 pre-MRI explantations. Implant displacement was the most common device malfunction (n = 69, 87.3%), and pain was the most common patient injury (n = 16, 53.3%). From 2015 to 2020, there were 566 adverse events and 62 pre-MRI explantations. The most common device malfunction was implant displacement (n = 365, 94.6%) and pain was the most common patient injury (n = 114, 63.3%). Only 64/114 (56.1%) reports after 2015 reported adherence to the recommended MRI protocol. No adverse events occurred in patients with synchrony diametric-magnet CIDs. CONCLUSION: Despite the advent of FDA-approved MRI-safe diametric magnet devices, implanted patients are still experiencing injury, explantation, and device malfunction, and providers are reporting poor compliance with MRI safety protocols.

Adverse events associated with Bonebridge and Osia bone conduction implant devices.

PURPOSE: Active transcutaneous Bone Conduction Implants (BCIs) are relatively new to the market and may offer improved outcomes while reducing skin-related complications associated with previous models. The purpose of this study is to examine medical device reports (MDRs) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events with the active, transcutaneous BCIs, Bonebridge and Osia. METHODS: A search of the FDA MAUDE database was conducted using product code "PFO" (for Active Implantable Bone Conduction Hearing System), brand names "Bonebridge" and "Osia." Data was collected on device malfunction, patient injury, inciting events, and subsequent interventions between July 1, 2018 and November 1, 2020. RESULTS: The search query yielded 83 reports that met inclusion criteria, 56 regarding Bonebridge and 27 regarding Osia. A total of 91 adverse events were reported, including 45 device malfunctions and 46 patient injuries. Of all adverse events reported for Bonebridge, 15 (26.3%, 15/57) documented patient injuries, while the majority (73.7%, 42/57) documented device malfunctions. Of all adverse events reported for Osia, 3 (8.8%, 3/34) were reported concerning malfunctions, while 31 (91.2%, 31/34) were reported for patient injuries. The most commonly reported adverse events included lack of conduction or hearing (n = 26, 28.6%), infection (n = 14, 15.4%), and intermittent or reduced conduction or hearing (n = 12, 13.2%). From the MAUDE database reported adverse events and the total number of Osia implants given to us from Cochlear over this 28 month period, we estimate patient injuries to occur in roughly 2.1% of patients. CONCLUSION: There are limitations to the database which make systemic analysis challenging. This study suggests that patients with transcutaneous, active BCIs may be experiencing fewer soft tissue injuries, but similar device malfunctions as those with previous models.

Tracheotomy in COVID-19 Patients: A Systematic Review and Meta-analysis of Weaning, Decannulation, and Survival.

OBJECTIVES: A systematic review and meta-analysis was conducted to determine the cumulative incidences of decannulation and mechanical ventilation weaning in patients with coronavirus disease 2019 (COVID-19) who have undergone a tracheotomy. Weighted average mean times to tracheotomy, to decannulation, and to death were calculated from reported or approximated means. DATA SOURCES: PubMed, SCOPUS, CINAHL, and the Cochrane library. REVIEW METHODS: Studies were screened by 3 investigators independently. Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines were followed. Studies including patients with COVID-19 who underwent a tracheotomy were identified. Studies without reported mechanical ventilation weaning or decannulation were excluded. Data were pooled using a random-effects model. RESULTS: After identifying 232 unique studies, 18 articles encompassing outcomes for 3234 patients were ultimately included for meta-analysis, with a weighted mean follow-up time of 28.6 ± 6.2 days after tracheotomy. Meta-analysis revealed that 55.0% of tracheotomized patients were weaned successfully from mechanical ventilation (95% CI, 47.4%-62.2%). Approximately 34.9% of patients were decannulated successfully, with a mean decannulation time of 18.6 ± 5.7 days after tracheotomy. The pooled mortality in tracheotomized patients with COVID-19 was 13.1%, with a mean time of death of 13.0 ± 4.0 days following tracheotomy. CONCLUSION: At the current state of the coronavirus pandemic, over half of patients who have required tracheotomies are being weaned off of mechanical ventilation. While 13.1% patients have died prior to decannulation, over a third of all tracheotomized patients with COVID-19 reported in the literature have undergone successful decannulation.

Adverse events associated with the Inspire implantable hypoglossal nerve stimulator: A MAUDE database review.

BACKGROUND: Implantable hypoglossal nerve stimulation (HNS) has been found to be a safe and effective therapy for patients with obstructive sleep apnea, and patient adherence to treatment has been found to be as high as 86% after 12 months of therapy. OBJECTIVE: The purpose of this study is to review the medical device reports (MDRs) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events related to HNS therapy that could hinder compliance. METHODS: A search of the FDA MAUDE database was conducted using the product code "MNQ" for "Inspire stimulator for sleep apnea." Reports of adverse events associated with Inspire for sleep apnea from January 2000 to May 2020 were included for analysis. From these included reports, event variables were collected, including event setting, adverse event to patient, iatrogenic injury, device malfunction, interventions, and root causes. Results were compiled and reviewed. RESULTS: The search query yielded 180 reports that met inclusion criteria, containing a total of 196 adverse events. The most commonly reported adverse events to patients were infection (n = 50, 34.2%), neuropraxia (n = 22, 15.1%) and hematoma/seroma (n = 17, 11.6%). A total of 83 adverse events (42.3%) required reoperation. The most common reoperations performed for adverse events to patients were explantation (n = 30, 46.2%) and device repositioning/lead revision (n = 24, 36.9%), while the most common reoperation performed for device malfunctions was device replacement (n = 10, 55.6%). CONCLUSION: In attempting to further improve patient compliance, understanding these device malfunctions and adverse events related to HNS implantation or usage is crucial for the identification of potential causes of patient non-adherence.