MAUDE Adverse Event Report: UNKNOWN CARDIAC MONITOR IMPLANT; DETECTOR AND ALARM, ARRHYTHMIA

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Burning Sensation (2146); Urticaria (2278); Blister (4537); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2022

Event Type  Injury  

Event Description

Patient called with complaint about her implanted cardiac monitor.She had it implanted on (b)(6) 2022 and explanted on (b)(6) 2023.The implant caused her to become very sick and bedridden, causing extreme pain, burning and bad rash at the implant site.Upon its removal, patient states that she was in an "anaphylactic state for three weeks".She also has body aches and pain, fever blisters, hive outbreaks, cold sores that have "turned into herpes and has happened approximately 5 times since having the implant." patient believes her symptoms are a result of the silicone that encases the cardiac implant.She states that this procedure is being done to many people and that patients are not being warned about the silicone on it and that there is no clear warning, on or about the device, and its possible health effects.

• Brand Name: CARDIAC MONITOR IMPLANT
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16264753
• MDR Text Key: 308504782
• Report Number: MW5114561
• 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: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: VALTREX.
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female