MAUDE Adverse Event Report: MEDSONIX SOUND WAVE PAIN RELIEF; MASSAGER, THERAPEUTIC, ELECTRIC

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

Patient Problems Atrial Fibrillation (1729); Palpitations (2467)

Event Date 06/26/2019

Event Type  Injury  

Event Description

In an attempt to deal with my chronic pain/fibromyalgia, i signed up for a session of sound wave pain relief through (b)(6).They use a device which is manufactured by medsonix, and they state it is an fda cleared class 1 medical device.After about 10 minutes of the 30 minute session, i noticed that my heart was palpitating in an unusual and scary fashion.I do have a history of premature ventricular contractions (pvcs), but most of the time the pvcs are not noticeable.My (b)(6) watch has the capability of detecting atrial fibrillation, so instead of bolting from the room which contained the device (which was my first instinct), i decided to do an ekg on my watch.The first two ekg's said the 30 second readings were "inconclusive".The third was a definite "atrial fibrillation".I have had lots of ekgs, holter monitors, king of hearts (30 day heart monitor), and never before had any incidents of atrial fibrillation.There is a history of a-fib in my family, but i did not until that moment have a personal history of a-fib.I believe this device could seriously harm some people.It may help alleviate pain in some.The lady running the place seemed genuine and had a story about this device being the only thing that helped her chronic pain, and i believe her.I do not have an issue with the (b)(6) office of "(b)(6)".But, this device needs to be studied more; way, way more.The manufacturer needs to be held accountable.The manufacturer's website states there have been no reports of adverse events.Atrial fibrillation is clearly an adverse event.Fda safety report id # (b)(4).

• Brand Name: SOUND WAVE PAIN RELIEF
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): MEDSONIX
• MDR Report Key: 8759753
• MDR Text Key: 150174725
• Report Number: MW5087836
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Reporter Country Code: AF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 74