MAUDE Adverse Event Report: CALA HEALTH, INC. CALA TRIO; EXTERNAL UPPER LIMB TREMOR STIMULATOR

Model Number CT1-STT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arrhythmia (1721); Muscle Weakness (1967); Loss of consciousness (2418); Confusion/ Disorientation (2553)

Event Date 04/02/2023

Event Type  Injury  

Event Description

(b)(6) has essential tremor, right hand.In conference with his nurse practitioner, they decided to try the cala trio, an elec.Stimulation wristband.He used it friday 1 session of 40 mi, saturday 1 session of 40 min.Sunday morning he woke up feeling "discombobulated:, within 90 min of waking, he faded out, arms limp, non responsive, may have been unconscious.Finally woke him , he was confused, called 911 at 10:15 am.At hosp fast irregular heartbeat.120-150 rate.11:30 a.M.Heart went back into sinus rhythm on its own.And stayed ok.Kept overnight tests run.All tests good.Eeg, cat brain, chest xray, heart ultrasound, bloodwork all good.No reason was found the event.They called it afib initial onset.Sent home prescription for 25 mg toprol and baby aspirin.To follow up with cardio in 2 weeks.The cala trio device is the only new thing.Staff kept asking, what is new in your life.And in a few hours, we realized that device is the only change.I called company and asked if they had clinical trialed it on anyone with a tbi.He has a tbi from skull fracture, subdural hematoma in 1994.They said no trial on tbi.It says not to use if seizures.He has never had a seizure.He had no contraindication to use this device.We believe it caused the heart problems and needs more testing.We may be the first to experience this and want to protect others from it.Eeg: no epileptiform abnormalities or seizures were identified in this record.Photo stimulation was performed at multiple flash frequencies and did not result in a change in the background.

• Brand Name: CALA TRIO
• Type of Device: EXTERNAL UPPER LIMB TREMOR STIMULATOR
• Manufacturer (Section D): CALA HEALTH, INC.
• MDR Report Key: 16727833
• MDR Text Key: 313245186
• Report Number: MW5116561
• Device Sequence Number: 1
• Product Code: QBC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: CT1-STT
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: FLOMAX; MULTI VITAMIN; PEPCID; PROBIOTIC
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White