MAUDE Adverse Event Report: LIFEWATCH SERVICES INC. LIFEWATCH MOBILE CARDIAC TELEMETRY 1-LEAD

Model Number MCT 1L PATCH UNIVERSAL GATEWAY

Device Problem Vibration (1674)

Patient Problems Itching Sensation (1943); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Weakness (2145); Burning Sensation (2146); Tingling (2171); Anxiety (2328); Palpitations (2467); Sleep Dysfunction (2517)

Event Date 06/22/2017

Event Type  Injury  

Event Description

Lifewatch mobile cardiac telemetry 1-lead (b)(6).The heart monitor caused a buzzing in my feet for a few seconds every 1 and a half minutes, mostly my left foot.This was consistent over days and locations.I called the manufacturer support on day 4.The monitor was removed and replaced.The second monitor, shortly after i started wearing it, began a buzzing that grew stronger in both feet.This grew to the lower legs and had increasing light leg weakness that made mobility more difficult.On day 4, when i awoke with light weakness in my hands and a second day with light warm flushing over my shoulders and down my arms, and there seemed to feel some disturbance in my abdomen, the monitor was removed with a call to the manufacturer support.The buzzing was strong enough and cycled continuously that i had a pair of electricians to my old house to ensure it was electrically properly grounded.A neighbour, retiree of the utility, said it sounded like a wireless issue.This may be consistent with bluetooth technology issues.Afterwards, i found a lot of similar complaints in some (b)(6) internet forums about their heart rate monitors sold in many retail stores.I've learned that bluetooth does not go through the body like cell phone transmissions.Instead, the bluetooth frequency is absorbed by water molecules, like microwave ovens, which causes vibration.I now see instructions for headsets with bluetooth to have the headset and phone on the same side of the body so they work together because of body absorption.I had leg stiffness and some "pings" for the next couple of days, as some (b)(6) users have had, and light nausea and leg weakness dogged me for a couple of more days.Example (b)(6) posts with similar problems (bluetooth issues): i strapped my phone on with cellular and bluetooth on - same problem.Switched them both off - no problem.People call it zapping, it bcz it almost feels the same as current passing through.Unfortunately, i have been experiencing the same.Sharp electric impulses especially in my toes, spasms in my legs.If i had bluetooth turned on then i start to develop pains after a few days of continuous use.I've had exactly the same issue.Tingling sensation, even slightly painful, through the hand, wrist, forearm and into ribcage area.Switched off bluetooth and the problem has gone away! i started experiencing the same symptoms as you did.I really started freaking out last night.I had very weird heart palpitations, flutters and restlessness.I am glad i thought of taking the (b)(6) off and as soon as i did i was able to sleep without a problem.You are not alone as i am sure there are a number of us who have experienced this horrible side effects.I most certainly will minimize my bluetooth usage.The problem was mended by switching off the bluetooth.Have worn the device all day every day since with no side effects at all - it was just the bluetooth integration that was tracking my route for a run.What is that bluetooth doing? very worrying! i wear it on my left wrist.I wore my tracker to bed and was awakened to a very sharp, excruciating stabbing pain in my feet/toe.That was the last straw! maybe it is the combination of the bluetooth, wifi, 24 hr connection with my phone, flashing lights and wearing it 24 hours a day.I'm not sure.I do know that once i stopped wearing it, i no longer have any itching/stinging or problems sleeping.

• Brand Name: LIFEWATCH MOBILE CARDIAC TELEMETRY 1-LEAD
• Type of Device: LIFEWATCH MOBILE CARDIAC TELEMETRY 1-LEAD
• Manufacturer (Section D): LIFEWATCH SERVICES INC.
• MDR Report Key: 6713882
• MDR Text Key: 80144767
• Report Number: MW5070982
• Device Sequence Number: 1
• Product Code: DXH
• 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: 07/12/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/08/2018
• Device Model Number: MCT 1L PATCH UNIVERSAL GATEWAY
• Device Catalogue Number: KIT ID K2817676
• Device Lot Number: BATCH NUMBER 060817-003
• Other Device ID Number: (ANDROID) VERIZON
• 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): Other; Required Intervention; Disability
• Patient Age: 69 YR
• Patient Weight: 70