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

Model Number AMSG3-E

Patient Problem Failure of Implant (1924)

Event Date 02/23/2024

Event Type  malfunction  

Event Description

The issue occurred (b)(6) 2024 when the patient reported to her doctor with a see doctor alert from the device.At the doctor's office an attempt was made to interrogate the device; however the device was not able to communicate 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 failure.The patient decided to have the device explanted and replaced and that procedure was performed on (b)(6) 2024.The device was received at the decontamination center on (b)(6) 2024.It was decontaminated and returned to avertix for investigation in april, 2024.The following issue was created in the qms of avertix for this problem: issue 94 issue 48 was escalated to a complaint for investigation: complaint 65 complaint 65 was assigned to an existing capa for corrective and preventive action determinations: capa 12.

• Brand Name: GUARDIAN SYSTEM
• Type of Device: ACUTE CORONARY SYNDROME EVENT DETECTOR
• Manufacturer (Section D): AVERTIX MEDICAL INC.; eatontown NJ 07724
• MDR Report Key: 19051050
• MDR Text Key: 339630734
• Report Number: MW5153561
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AMSG3-E
• Device Lot Number: 121720V0209530000037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White