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

Model Number	100014514
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a ventricular tachycardia procedure, after catheters were inserted in the patient, a bent pin was found on the ensite amplifier resulting in cancellation of the procedure.When attempting to validate, it was noted that there was an amplifier error that mentioned a patch impedance error.The patch placement was verified and it was noted that there was a patch that was not glued on correctly.The patch was replaced, but the error message persisted.The physical status of the navlink was verified, but the issue persisted.Upon inspection, it was noted that there was a damaged pin on the ensite amplifier.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.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.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One ensite velocity¿ amplifier was received for evaluation.Visual inspection revealed the chassis and labels showed signs of discoloring and wear due to age.Visual inspection of the front panel ports identified broken/missing pins within the ablation connector port (pin location 40, +5v) and the navx connector port (pin location 69, system reference), reproducing the reported symptom.Power was applied to the amplifier and the amplifier passed power-on-self-test (post).The amplifier went status ready ¿green¿ and communicated with the test ensite computer.Evaluation of the board status showed all boards status are green indicating passing results.The reported event was able to be reproduced by visual inspection.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 physical damage to a pin within the navx connector 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.

• Brand Name: ENSITE VELOCITY¿ SYSTEM VELOCITY 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: 23496847
• Report Number: 2184149-2025-00175
• Device Sequence Number: 9115891
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: (01)05414734210713(10)6041362
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K141050
• 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,Followup
• Report Date (Section B): 04/17/2026

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: 100014514
• Device Catalogue Number: 100014514
• Device Lot Number: 6041362
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 03/23/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 02/15/2026; 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2017
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 110 KG