MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-R-AMP-02
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
At the start of an avnrt procedure, there was no catheter movement when four, different catheters were introduced into the body, causing a delay.There were no error messages.To troubleshoot, the left leg patches were exchanged, a new case was started, the catheter cables and catheters were exchanged, all catheters were fully defined and verified, the firmware was switched to voxel mode (despite no catheters being se tools) and back to navx mode, and the system reference sensors were exchanged and revalidated.The issue still persisted after troubleshooting.When catheters were in the heart (as observed by fluoroscopy), there was still no catheter movement and/or egm signals on ensitex or workmate claris.The procedure was successfully completed with no adverse patient consequences.
Additional Manufacturer Narrative
Additional information g3, g6, h2, h3, h6.The reported event could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
One ensite x amplifier, sn: (b)(6) was received for evaluation.The field reported event was not able to be replicated.The amplifier was powered on and then the amplifier booted to a solid green ¿ready¿ light emitting diode (led) status.This indicated the amplifier passed the power-on-self-test (post) and then successfully communicated with the test station tracker software.The intra-cardiac (ic) short test was then performed and was successful.The field service tool (fst) was then connected, and the amplifier passed post.The field functional test was then performed and was successful.Based on the information provided to abbott and the investigation performed, the reported event was not able to be confirmed, and the root cause remains undetermined as the returned amplifier passed all testing.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
This report includes an updated device investigation.

• 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: 23922058
• Report Number: 2184149-2025-00216
• Device Sequence Number: 9295762
• Product Code: DQK
• UDI-Device Identifier: 05415067034748
• UDI-Public: (01)05415067034748(10)9008219
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K242016
• 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,Followup,Followup
• Report Date (Section B): 04/23/2026

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: 9008219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 03/26/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 03/03/2026; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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