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 03/27/2023

Event Type  malfunction  

Event Description

Premature battery depletion of the patients guardian system imd resulted in the explant of the device on (b)(6) 2023.The initial issue occurred (b)(6) 2022 when the patient reported to her doctor with a see doctor alert from the device.At the doctor's office the implant was interrogated and it was determined that the device had experienced a device reset.However, the device recovered and was working correctly following that visit.The patient returned to the clinic for a routine follow-up visit on (b)(6) 2022.At that visit it was determined that the device could no longer be communicated with via 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), 2023.The device was decontaminated and returned to avertix for investigation a week later in april, 2023.The following issue was created in the qms of avertix for this problem: issue 48 issue 48 was escalated to a complaint for investigation: complaint 36 complaint 36 was assigned to capa for corrective and preventive action determinations: capa 12 the patient experienced no adverse events associated with the problem or the explant procedure.

• 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: 17585004
• MDR Text Key: 321714189
• Report Number: MW5144769
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2022
• Device Model Number: AMSG3-E
• Device Catalogue Number: 0212-2100-031#P16
• Device Lot Number: 120120V0209530000031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White