MAUDE Adverse Event Report: BIOTEL HEART/CARDIONET/LIFEWATCH MOBILE CARDIAC TELEMETRY 1 LEAD PATCH (MCT 1LP); DETECTOR AND ALARM ARRHYTHMIA

Model Number MCT 1LP

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Irritation (2076); Burning Sensation (2146)

Event Date 09/27/2018

Event Type  Injury  

Event Description

Due to possible heart arrhythmia, my cardiologist requested me to wear the mobile cardiac telemetry 1 lead patch (mct 1 lp) from biotel heart (cardionet & lifewatch) to monitor my heart rate for a month.After initial installation by the nurse on (b)(6) 2018, i had to apply a new patch on (b)(6) (as it was coming lose prematurely; it is supposed to stay on for a week), i had to adhere a new patch again on tuesday (b)(6) because it was malfunctioning ( i constantly got the message of lose skin contact, even though it was firmly attached to my skin).I accurately followed the procedure as i was taught and according to the instructions manual.On wednesday (b)(6), it malfunctioned a few times for a short period (same issue).On thursday, (b)(6), it kept malfunctioning constantly, so i replaced it again.Since that did not resolve the issue, i called the lifewatch help desk.After explaining what had happened over the past few days, the help desk support employee ( i didn't write down her name) seemed careless about what i had to say, and insisted that i go through the procedure of applying a new patch again with her on the phone.I reluctantly complied, as my skin was already quite tender from the shaving, scrubbing and sterilizing (with the provided alcohol wipes) before applying that patch earlier that morning (before the phone call).She walked me through the same procedure again (removing the patch, then shaving, scrubbing and sterilizing my skin), and the same issue occurred (message of lose skin contact).I was then transferred to a woman who was much more helpful and kind, and she agreed with me that the only solution was to send me a completely new kit.Since i had to return the current kit with all used patches, i had to remove the patch that i just applied again, after which my skin felt really sore and tender, leaving a large red mark.Even the following day and 2 days later), that area of my skin showed the exact shape of the patch in red and it felt like a severe sunburn.

• Brand Name: MOBILE CARDIAC TELEMETRY 1 LEAD PATCH (MCT 1LP)
• Type of Device: DETECTOR AND ALARM ARRHYTHMIA
• Manufacturer (Section D): BIOTEL HEART/CARDIONET/LIFEWATCH
• MDR Report Key: 7978717
• MDR Text Key: 124794104
• Report Number: MW5080625
• Device Sequence Number: 1
• Product Code: DSI
• 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: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MCT 1LP
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 74