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

Device Problems False Alarm (1013); Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 06/12/2023

Event Type  malfunction  

Event Description

The adhesive strip that attaches the boston scientific/preventis body guardian mini plus heart monitor is inadequate, problematic and poorly designed.Throughout my time wearing i continually got poor skin contact error messages even when it appeared to be securely attached.On some occasions pressing down on the strip multiple time would correct the problem but too often it would require a new strip when attaching a new strip on two occasions, the #1 tab broke off prior it's removal that allowed the adhesive to be exposed.I would also say the length of the #1 tab is too short.While wearing i received two alert calls within hours of each other.However, the person or recorded voice message was delivered both quickly and the last part of it was indistinct, run-on and unintelligible.I replayed it 5 times and was never able to understand the last part which i believe provided the call back extension information.Oh yes, the first message also referred to me as "doctor" was made me believe they had called the wrong number.Finally, i would also like to know why the patient is unable to get any feedback on the results or the reason for the alert and why it is necessary for the patient to wait to hear back the results from a physician many, many days after the usage has ended.Glucose monitors provide instant feedback that allows the patient to understand causality in real time.What safety reason could possibly preclude this from occurring with a heart monitor? it is a rare md or their office that in this day and age responds to patient calls in a timely manner.It often takes months for even an established patient to get an appointment, my monitoring ended at 1:00 am (b)(6).Today is the (b)(6) and i have yet to hear back from my physician's office although they did respond to the alert, i missed the call and never received another call back.Ref report: mw5118777.

• Brand Name: PREVENTICE BODY GUARDIAN MINI PLUS EL
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): BOSTON SCIENTIFIC/PREVENTICE TECHNOLOGIES, INC.
• MDR Report Key: 17199309
• MDR Text Key: 317948652
• Report Number: MW5118776
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• 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
• Treatment: LUTEIN; B COMPLEX; CALCIUM; FLAX SEED OIL; HORSETAIL; MAGNESIUM; RED CLOVER; SCULLCAP; VITAMIN D; VITAMIN E; VITAMIN E
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Race: White