MAUDE Adverse Event Report: PREVENTICE TECHNOLOGIES, INC. BODYGUARDIAN MINI (KIT D427L890498); DETECTOR AND ALARM, ARRHYTHMIA

Device Problems Product Quality Problem (1506); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  malfunction  

Event Description

My doctor prescribed for 14 days a heart monitoring device called body guardian.From preventice services a division of boston scientific.Kit number - d427l890498, on (b)(6) 2022 from day 1 the device is practically worthless and, in my opinion defective.The electrodes would not stay on my chest, i followed all instructions.I believe the adhesive is sub quality.I went to my cardiologist to get his nurse to put it on, she used a better adhesive and stated the adhesive was bad.Using surgical taped she tapped the monitoring device to my chest to get the electrodes to make contact with my skin.She also ordered from preventice another and hopefully better electrode.They never sent me the electrodes with a better adhesive to stick to my shaved skin.My complaint is the device is defective, not engineered correctly, the adhesive is defective, device kept falling off my body, it only stayed on when the nursed taped it to my body.The taping to my body is not in the instructions.I am sure any information on my heart beat is unreliable.I cannot believe that this device is approved by fda, and medicare and my insurance company is paying for it.I hope they take this device off the market, if someone really had a heart issue they find no benefit from the information and design of this medical device.I have pictures, documented my time trying to get this device to work and have the correct complaint forms that i found from the fda website.

• Brand Name: BODYGUARDIAN MINI (KIT D427L890498)
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PREVENTICE TECHNOLOGIES, INC.
• MDR Report Key: 15744458
• MDR Text Key: 303335073
• Report Number: MW5113096
• 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: 10/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1