MOTOROLA HEART MONITOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-14 for MOTOROLA HEART MONITOR manufactured by Lifewatch.

Event Text Entries

[36523409] Cardiologist ordered an event monitor for me (heart monitor). I was to use this for 12 days, and send it back to the company on (b)(6) 2016. I was instructed to wear the electrodes 24 hrs a day, only replacing them every three days and taking the lead wires off when showering. The first cellphone device did not transmit anything due to poor cellular reception. The new one was also very intermittent due to the same reason but that problem is not relevant to my complaint: on (b)(6), i noticed that i started to itch around the electrodes. I notified the company of such. I was told that they do have a different type of electrodes for people who are sensitive, however since i was returning the equipment on (b)(6), i felt that by the time they were sent to me, their equipment would no longer be in my possession, so the point of them sending these new ones was moot. Customer service then suggested to me that i should "place them n a different area, but within the same region", which i think would only expand the area of the allergic reaction. I found out by phoning on (b)(6) that the electrodes contain 5% of potassium chloride in a gel form. The tech support person did not know what the adhesive was made of. By (b)(6), i was completely broken out, red, itchy and very irritated in all four places that the electrodes were on my body. I now have to go to an allergist, at my expense, to receive a corticosteroid injection to relieve the allergic reaction. I did inquire as to who i should speak to during the day and who i should address this issue to. I was told to "just send an email to the 'complaint handling" department and address it to no one specifically". I also asked if anyone will get back to me; the answer was "no, probably not". This is a major heart monitoring company and no one will assume responsibility?! I cannot afford to pay for something that is solely their responsibility; they should have mentioned to me immediately during their first conversation with me, which was the night wherein they go over the instruction on the usage and application of the electrodes and lead wires, that if you think you might be allergic, "we do have other electrodes available", but no one mentioned anything about that to me. The name of this company is " (b)(6)". I do not have their actual mailing address, but their toll-free number is: (b)(6). I believe they may be in i(b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5059424
MDR Report Key5380899
Date Received2016-01-14
Date of Report2016-01-14
Date of Event2016-01-06
Date Added to Maude2016-01-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMOTOROLA HEART MONITOR
Generic NameMOTOROLA HEART MONITOR
Product CodeDXH
Date Received2016-01-14
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerLIFEWATCH


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-01-14

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