MAUDE Adverse Event Report: BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC. PREVENTICE BODY GUARDIAN MINI; DETECTOR AND ALARM, ARRHYTHMIA

Patient Problem Diaphoresis (2452)

Event Date 05/18/2023

Event Type  malfunction  

Event Description

I was prescribed the preventice remote cardiac monitor that has since been acquired by boston scientific.This phone based monitoring device required placement of a monitor on the chest wall, either the sternum or immediately adjacent.Approximately 6 portable monitors are supplied, the first of which was applied at my physician's office.I discussed with my cardiologist that the symptoms bringing me in for evaluation occurred while running 5-10k.He recommended wearing the device while running.During my first run with the device placed under the supervision of the physician staff, the adhesive dissolved due to perspiration around my 4k mark, leaving the monitor floating on my chest within my sports gear.I received a call from preventice about the data interruption, and i reported the attachment failure.I received instructions to try again with a new device.I subsequently went through all of the devices on various runs with the same outcome.I spoke with the rep again who state the adhesive does not withstand perspiration, and the company had no recommendations as to how to address this failure.I feel it is false advertising to market the device as appropriate for exercise or other intense activities.I've made a complaint to company website as well.The portable phone monitor and the chest units were returned to the manufacturer as per their instructions when i completed the testing cycle.Reference reports: mw5120498, mw5120500, mw5120501, mw5120502, mw5120503.

• Brand Name: PREVENTICE BODY GUARDIAN MINI
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.
• MDR Report Key: 17450273
• MDR Text Key: 320500855
• Report Number: MW5120499
• 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: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White