MAUDE Adverse Event Report: LIFEWAVE, INC. LIFEWAVE X39 PATCHES; ADHESIVE BACKED THERMAL SKIN PATCHES

Device Problem Use of Device Problem (1670)

Patient Problems Headache (1880); Pain (1994)

Event Date 04/30/2023

Event Type  Injury  

Event Description

I am a family medicine doctor in (b)(6) but in this situation also the consumer.I tried the lifewave x39 patches that i was gifted from a friend trying to help with my chronic ankle pain.I couldn't find much info at all on it (other than testimonials and very vague product description- its not supposed to contain any active medications in it) so figured it was pretty benign and gave it a try.On my second patch i developed a sudden severe migraine that only got worse with my triptan medication.Ended up in er and had to take multiple medications for pain control.Thankfully negative ct/cta.I'm wondering if there is actually something (a drug) in medication that particularly interfered with my triptan.I couldn't find any safety studies on it or contraindications.Unfortunately er doctor did not do drug screen.

Event Description

I am a family medicine doctor in (b)(6) but in this situation also the consumer.I tried the lifewave x39 patches that i was gifted from a friend trying to help with my chronic ankle pain.I couldn't find much info at all on it (other than testimonials and very vague product description- its not supposed to contain any active medications in it) so figured it was pretty benign and gave it a try.On my second patch i developed a sudden severe migraine that only got worse with my triptan medication.Ended up in er and had to take multiple medications for pain control.Thankfully negative ct/cta.I'm wondering if there is actually something (a drug) in medication that particularly interfered with my triptan.I couldn't find any safety studies on it or contraindications.Unfortunately er doctor did not do drug screen.

Event Description

Additional information received on 05/10/2023 for mw5117234.Updating procode and device manufacturer.

• Brand Name: LIFEWAVE X39 PATCHES
• Type of Device: ADHESIVE BACKED THERMAL SKIN PATCHES
• Manufacturer (Section D): LIFEWAVE, INC.; 9775 businesspark ave; san diego CA 92131
• MDR Report Key: 16868825
• MDR Text Key: 314627357
• Report Number: MW5117234
• Device Sequence Number: 3789941
• Product Code: OMW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2023
• Patient Sequence Number: 1
• Treatment: CALCIUM ; CALCIUM ; MAXALT AS NEEDED; MAXALT AS NEEDED; PROGESTIN BIRTH CONTROL ; PROGESTIN BIRTH CONTROL ; PROTONIX; PROTONIX; TRIPTAN ; TRIPTAN ; VITAMIN D; VITAMIN D
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Hispanic
• Patient Race: White