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

Model Number AMSG3-E

Patient Problem Failure of Implant (1924)

Event Date 03/13/2023

Event Type  malfunction  

Event Description

Patient was implanted with a guardian device on (b)(6) 2022.Patient was alerted by the guardian system via a see doctor alert on (b)(6) 2023 and made an appointment to see the cardiologist on the following day.At that appointment the device was interrogated and it was identified that a device reset had occurred.Further evaluation indicated that the device could no longer reliably communicate with the programmer.The physician was notified and discussed the problem with the patient and indicated that the device should be explanted so that the root cause of the problem could be identified.The patient agreed to the explant and the device was explanted on (b)(6) 2023.The device was sent to decontamination facility and was received at avertix medical inc.On april 13, 2023.An investigation was initiated to determine the root cause of the problem.The following issue was created in the qms of avertix for this problem: issue 67 issue 67 was escalated to a complaint for investigation: complaint 48 complaint 48 was assigned to capa for corrective and preventive action determinations: capa 12 the patient experienced no adverse events associated with this problem other than the explant procedure.

• Brand Name: AVERTIX MEDICAL INC. GUARDIAN SYSTEM
• Type of Device: ACUTE CORONARY SYNDROME EVENT DETECTOR
• Manufacturer (Section D): AVERTIX MEDICAL INC.
• MDR Report Key: 17585300
• MDR Text Key: 321724500
• Report Number: MW5144780
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: AMSG3-E
• Device Catalogue Number: 0212-2100-031#P16
• Device Lot Number: 020120V0209530000031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2023
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Race: White