MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ X AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-R-AMP-02
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
After the patient was on the table for an atrial fibrillation procedure, a pin in the ampere connect port of the amplifier was bent resulting in cancellation of the procedure.The led on the amplifier was red when it was booted up and restarting it did not resolve the issue.The ports of the amplifier were then visually inspected.It was then noted that a pin in ampere connect port was bent.As the issue could not be resolved the procedure was cancelled.The issue has since been resolved by replacing the amplifier and the procedure was rescheduled.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One ensite x amplifier was received for evaluation.For evaluation purposes the port 3 and port 4 small form-factor pluggable (sfp) were temporarily exchanged.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 identified that channel 53 (ablation 2) was electrically open.Any electrical open will cause non-functionality, unexpected results, or channel artefacts, which duplicates the reported symptom.Based on the information provided to abbott and the investigation performed, the root cause was attributed to physical damage to the pins within the ablation port.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: ENSITE¿ X AMPLIFIER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE 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: 21988495
• Report Number: 2184149-2025-00078
• Device Sequence Number: 15573222
• Product Code: DQK
• UDI-Device Identifier: 05415067034748
• UDI-Public: (01)05415067034748(10)10390371
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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: 10390371
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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