MAUDE Adverse Event Report: BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC. BODYGUARDIAN ONE; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 231206

Patient Problems Erythema (1840); Itching Sensation (1943); Caustic/Chemical Burns (2549)

Event Date 12/27/2023

Event Type  Injury  

Event Description

Burned skin using boston scientific continual ekg (electrocardiogram) monitoring device bodyguardianone model 231206 serial #: (b)(6).Skin burned from the adhesive used to hold electrodes on skin despite removing and cleaning skin and reapplying in new locations every 3 days.Stopped use of device for 7 days to allow skin to heal before continuing use.There should have been a warning about this.Additionally, when i asked my cardiologists receptionist to file an adverse event, she claimed to not know how to find the form and did nothing.Skin is still healing and scabbed over despite removing last electrodes 4 days ago.Use of continuous heart monitoring device required application of electrodes for 3-day periods.After a day the site of application began to itch and burn and when removed after 3 days of use, skin was red and burned.Discontinued use of device for 7 days to allow skin to heal mid-use.Additionally, device batteries did not function correctly and most of the time i only had one functioning battery.Very flawed study with limited data due to inability to get a second battery sent for more than 10 days when beginning study.

• Brand Name: BODYGUARDIAN ONE
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.
• MDR Report Key: 18544170
• MDR Text Key: 333384407
• Report Number: MW5150541
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 231206
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2024
• Patient Sequence Number: 1
• Treatment: METFORMIN.
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White