MAUDE Adverse Event Report: VIVAQUANT RX-1 MINI REMOTE CARDIAC MONITORING SYSTEM; TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Chest Pain (1776); Erythema (1840); Tachycardia (2095); Shock from Patient Lead(s) (3162)

Event Date 01/20/2022

Event Type  Injury  

Event Description

Pt states that on thursday, (b)(6) 2022 she had a the rx-1 mini remote cardiac monitoring system placed and that in the evening she began experiencing intermittent tingling and shock sensations that she describes as a low voltage tens machine.Pt reports that she dismissed these sensations as possibly related to her preexisting nerve condition since they were faint.Pt notes that she was instructed to charge the monitor for about 20 minutes at some point in the day and states around 4pm she removed it to charge while she showered.Pt states that after showering, drying off and putting on her clothes she went to place the device back on her chest and received a jolt.Pt reports that the shock caused her to double over in pain and stop in her tracks.Pt states she immediately contacted (b)(6) who she notes monitors the device and alleges she was instructed by a representative to remove the device and consult her cardiologist for a check up.Pt notes that she has placed a call with her cardiologist and is waiting to hear back.At present pt states she has a circular red mark on her chest where the lead was located, that her upper left chest is sore and that her heart has been racing more since the incident.

• Brand Name: RX-1 MINI REMOTE CARDIAC MONITORING SYSTEM
• Type of Device: TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE
• Manufacturer (Section D): VIVAQUANT
• MDR Report Key: 13344393
• MDR Text Key: 284527241
• Report Number: MW5106952
• Device Sequence Number: 1
• Product Code: DXH
• 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: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female