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 08/23/2023

Event Type  malfunction  

Event Description

Premature battery depletion of the patients guardian system amsg3-e imd.The initial issue occurred (b)(6), 2023 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 could no longer communicate with the physician programmer afterwards.The physician was made aware of the issue and the physician spoke to the patient at that time and indicated the options available to her: explant and replacement, explant without replacement, or leave in place.The patient has not yet decided what option they will select.The following issue was created in the qms of avertix for this problem: issue 79, issue 79 was escalated to a complaint for investigation: complaint (b)(4); complaint (b)(4) was assigned to capa for corrective and preventive action determinations: capa 12.

• 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: 17737296
• MDR Text Key: 323392665
• Report Number: MW5145578
• 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: 09/08/2023

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 Model Number: AMSG3-E
• Device Lot Number: 011121V0210150000038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White