ELECTRICAL STIMULATION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-13 for ELECTRICAL STIMULATION manufactured by Unk.

Event Text Entries

[117140380] On (b)(6) 2018, i attended an appt at a chiropractic clinic for electrical stimulation therapy and was wearing an iwatch on my left arm with the face of the watch towards my wrist. Shortly after the therapy started, i received a shooting pain which radiated from my neck where the stimulator pads were placed to my left wrist where the iwatch was located. It subsided and i continued therapy for a few mins. I have since had shooting pains from my neck to my wrist and muscle twitching in my neck which is markedly worse when i am wearing the iwatch. As such, i have stopped wearing the watch and will be reporting it to the chiropractor on monday. I am a registered nurse and it really has me concerned, something happened between the electrical stimulation machine and the iwatch that was significant enough to effect the nerves in my arm now 2 days post treatment. This may not be the right forum for me to relay this experience but i feel that it's important enough to have it documented. I love apple products and have owned an iphone for many years. I'm not saying that iwatches should be prohibited but it may be good to caution people to not use them with electrical therapies.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5079135
• MDR Report Key: 7780325
• Date Received: 2018-08-13
• Date of Report: 2018-08-11
• Date of Event: 2018-08-09
• Date Added to Maude: 2018-08-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ELECTRICAL STIMULATION
• Generic Name: STIMULATOR, NERVE, TRANSCUTANEOUS
• Product Code: GZJ
• Date Received: 2018-08-13
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-08-13