MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X AMPLIFIER; Computer, diagnostic, programmable

Model Number	ENSITE-R-AMP-02
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One ensite x amplifier (sn: (b)(6)) was received for evaluation.The intra-cardiac (ic) short test was performed and identified that channels 54 and 56 were electrically open.It was noted that with pressure placed on the ampereconnect port all the 53-56 channels could become intermittent (non-functional or functional).The reported symptom was isolated to channel electrical intermittent open(s) between the port connector and the front plane assembly.Based on the information provided to abbott and the investigation performed, the reported event was able to be confirmed, and the root cause was attributed to intermittent electrical opens to channel 53-56 between the port and the front plane assembly.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.
Event or Problem Description
During a typical afl procedure, there was a procedural delay.It was noted that all of the electrodes on the tactiflex catheter had noise on them, and the catheter appeared distorted on the gui.Troubleshooting included rebooting, replacing the tactiflex catheter, replacing the rf cables, replacing the ampereconnect cable, replacing the ampere, and replacing the tactisys, but the issue persisted.The amplifier was replaced, and the issue was resolved.

• Brand Name: ENSITE¿ X AMPLIFIER
• Common Device Name: Computer, diagnostic, programmable
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24899061
• Report Number: 2184149-2026-00108
• Device Sequence Number: 18603073
• Product Code: DQK
• UDI-Device Identifier: 05415067034748
• UDI-Public: (01)05415067034748(10)10609199
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K202066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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
• Operator of Device: Health Professional
• Device Model Number: ENSITE-R-AMP-02
• Device Catalogue Number: ENSITE-R-AMP-02
• Device Lot Number: 10609199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown