MAUDE Adverse Event Report: IMPACT CRYOTHERAPY (ATLANTA GA) CRYOTHERAPY CRYOSAUNA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Chest Tightness/Pressure (2463)

Event Date 12/04/2018

Event Type  Injury  

Event Description

I spoke with dr (b)(6), fda center for devices and radiological health, on (b)(6) and he encouraged me to submit this report.On (b)(6) 2018 at approx 5:45 pm, i had a heart attack in a whole body cryotherapy (wbc) chamber contained within a van parked near the office of my physical therapist in (b)(6).The pt who owns and operates this is (b)(6).All van doors were closed and mr (b)(6) said he had an oxygen monitor.The unit used liquid nitrogen.With pressure and pain in my chest, i immediately went to the emergency room and was admitted to (b)(6) hosp in (b)(6).An ekg showed normal results.The attending emergency room physician, dr (b)(6), said my blood work showed elevated heart enzymes (troponin).A second blood test indicated my troponin levels were rising further.Dr (b)(6) said this indicated heart attack.I was given two doses of nitroglycerin which stopped the pain and pressure in my chest.I was admitted to the hosp.The attending cardiologist, dr (b)(6), performed a cardiac cath the next morning and reported heart damage.He observed no blockage and little plaque.He said he believed my arterial veins constricted from the wbc cold temperature and my heart spasmed.I've previously had approx.15 wbc sessions.I use wbc to reduce inflammation caused by rheumatoid arthritis.I'm (b)(6), physically fit and have been a runner for 40 years.I understand wbc is unregulated.I hope my info will prevent this event from happening to others using wbc.

• Brand Name: CRYOTHERAPY CRYOSAUNA
• Manufacturer (Section D): IMPACT CRYOTHERAPY (ATLANTA GA)
• MDR Report Key: 8627723
• MDR Text Key: 145920918
• Report Number: MW5086780
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 58