MAUDE Adverse Event Report: AVERTIX MEDICAL INC. THE GUARDIAN SYSTEM; ACUTE CORONARY SYNDROME EVENT DETECTOR

Model Number AMSG3-E

Patient Problem Failure of Implant (1924)

Event Date 11/15/2023

Event Type  malfunction  

Event Description

Premature battery depletion of the patient's guardian system imd resulted in the explant of the device on (b)(6) 2023.The initial issue occurred when the patient reported to his doctor for a scheduled visit and the implant could not be interrogated with the programmer.The physician was made aware of the issue and the physician spoke to the patient at that time and indicated that the device should be explanted in order to perform an investigation to determine the root cause of the issue.The patient decided to have the device explanted and replaced and that procedure was performed on (b)(6) 2023.The device was decontaminated and returned to avertix for investigation.The following issue was created in the qms of avertix for this problem: issue 83 which was escalated to a complaint for investigation: complaint (b)(4).Complaint (b)(4) was assigned to capa 12 for corrective and preventive action determinations.The patient experienced no adverse events associated with the alert or the explant procedure.

• Brand Name: THE GUARDIAN SYSTEM
• Type of Device: ACUTE CORONARY SYNDROME EVENT DETECTOR
• Manufacturer (Section D): AVERTIX MEDICAL INC.; eatontown NJ 07724
• MDR Report Key: 18394252
• MDR Text Key: 331401840
• Report Number: MW5149541
• Device Sequence Number: 1
• Product Code: QBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AMSG3-E
• Device Catalogue Number: 0212-2100-031#P16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White