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

Model Number AMSG3-E

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2023

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.The patient returned to see the doctor on (b)(6) 2023.At that appointment the device could no longer reliably communicate with the programmer.The physician was notified and discussed the problem with the patient as well as the options available to them.The patient and patient's husband indicated they will meet again on (b)(6) 2023, to indicate their decision at that time.This problem will be investigated when the device is returned to avertix after explant.The following issue was created in the qms of avertix for this problem: issue 77 issue 77 was escalated to a complaint for investigation: complaint 55 complaint 55 was assigned to capa for corrective and preventive action determinations: capa 12 the patient has not experienced any adverse events as a result of this problem.

• Brand Name: AVERTIX MEDICAL INC. GUARDIAN SYSTEM
• Type of Device: ACUTE CORONARY SYNDROME EVENT DETECTOR
• Manufacturer (Section D): AVERTIX MEDICAL INC.; eatontown NJ 07724
• MDR Report Key: 17585080
• MDR Text Key: 321725495
• Report Number: MW5144773
• 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: 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: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: AMSG3-E
• Device Catalogue Number: 0212-2100-031#P16
• Device Lot Number: 120120V0209530000031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White