MAUDE Adverse Event Report: AVERTIX MEDICAL INC. THE 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 patient's guardian system imd.The initial issue occurred on (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 and could no longer 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 has not yet made a decision on whether to have the device explanted.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).Once the device is explanted and can be examined, a determination on whether or not to assign the complaint to a capa will be made.The patient has experienced no adverse events associated with the problem.

• Brand Name: THE GUARDIAN SYSTEM
• Type of Device: ACUTE CORONARY SYNDROME EVENT DETECTOR
• Manufacturer (Section D): AVERTIX MEDICAL INC.; eatontown NJ 07724
• MDR Report Key: 18394265
• MDR Text Key: 331443442
• Report Number: MW5149542
• 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: 12/20/2023

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: Health Professional
• Device Model Number: AMSG3-E
• Device Catalogue Number: 0212-2100-031#P16
• 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: 12/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White