Study: NCT04577118

Adverse event: Altered mental state
Serious: yes
Organ System: Psychiatric disorders
Notes: Altered mental state as reported by daughter to ER doctor. Patient has not returned for follow-up visit due to non-associated medical problems. Ongoing contact being made to clinic to reschedule.
Frequency: 1 affected / 21 at risk

Adverse event: Patient hospitalization following knee surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: Patient hospitalization following knee surgery. Knee pain pre-existing prior to surgery per patient/daughter report (ortho note history in medical file)
Frequency: 1 affected / 21 at risk

Adverse event: Resistance with iotaSOFT
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Resistance noted at 20mm with electrode array insertion attempted to 24mm. Intra-operative fluoroscopy showed electrode was coiled in the cochlea. After the tip fold over, per protocol, electrode was removed and inserted manually. Resolved.
Frequency: 1 affected / 21 at risk

Adverse event: No stimulation with device
Serious: no
Organ System: Ear and labyrinth disorders
Notes: . Imaging was re-examined and identified a pre-existing temporal bone fracture crossing the internal auditory canal with scarring of the cochlear nerve (implant side). Subject withdrawn from study.
Frequency: 1 affected / 21 at risk

Adverse event: Drainage at implant site
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Patient reported drainage at implant site. This is identified risk of cochlear implantation surgery as captured in labeling and literature.
Frequency: 1 affected / 21 at risk

Adverse event: Bruising and dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Bruising and dizziness reported by patient following surgery. This is identified risk of cochlear implantation surgery as captured in labeling and literature.
Frequency: 1 affected / 21 at risk

Adverse event: CSF Leak
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Investigator used otologic drill for pilot hole for motor platform resulted in small CSF leak. Repaired and stopped with fascia and bone wax intraoperatively. No leak at closure. Surgery completed without further consequence or complications.
Frequency: 1 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: No hospitalization necessary. Was seen by provider on 3-3-21. Recommended vestibular rehab locally. Based on time to onset of reported symptoms (74 days after surgery) it is unlikely this is related to use of the iotaSOFT during implantation.
Frequency: 1 affected / 21 at risk

Adverse event: Incision coming open at CI site as seen at 2-week post-op visit.
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Physician addressed by adding small additional suture. At subsequent visit (activation), healing issue resolved and activation occurred. This is identified risk of cochlear implantation surgery as captured in labeling and literature
Frequency: 1 affected / 21 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Tinnitus when pushes on implant site. Patient reported tinnitus prior to surgery and by 1-month visit tinnitus 'better'. This is identified risk of cochlear implantation surgery as captured in labeling and literature.
Frequency: 1 affected / 21 at risk

Adverse event: Pain at incision
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Pain at incision w/ headache. This is identified risk of cochlear implantation surgery as captured in labeling and literature.
Frequency: 1 affected / 21 at risk

Adverse event: Swelling of face and eye area
Serious: no
Organ System: Eye disorders
Notes: Swelling in face and eye area on side of implant site. This is identified risk of cochlear implantation surgery as captured in labeling and literature. Vastly improved at 2-week follow-up
Frequency: 1 affected / 21 at risk

Adverse event: Facial Stim
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Facial stim and poor electrode response. At follow-up appointment (activation) the facial stim resolved with widening the pulse width of signal. Electrodes 11 and 12 still no response as surgeon elected shallow insertion
Frequency: 1 affected / 21 at risk