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

Model Number	100014514
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the atypical flutter procedure, self-test issues with the amplifier required multiple troubleshooting measures which resulted in a procedural delay.The amplifier was exchanged and the procedure was completed with no adverse consequences to the patient.The patient was on the table under general anesthesia and catheters were in place, but when the amplifier was turned on, it would not pass the automatic self-test, there was a flashing orange light.The amplifier was turned on and off multiple times without resolution.The delay to the procedure was approximately 2 hours.The amplifier was exchanged and the procedure was completed with no adverse consequences to the patient.
Event or Problem Description
Device returned.Updated final report needed to address analysis.
Additional Manufacturer Narrative
One ensite velocity¿ amplifier was received for evaluation at tech center.The reported event was not able to be duplicated.Evaluation testing was successful.Evaluation of the logs revealed no observable symptoms found within the logs.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.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.
Additional Manufacturer Narrative
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.No capa is required; the root cause of the reported issue could not be confirmed to be a manufacturing, design, or quality system related occurrence.The reported issue will continue to be monitored for trends and reviewed in qdr (quality data review).
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18030250
• Report Number: 2184149-2023-00212
• Device Sequence Number: 12240760
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 06/19/2024

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
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 11/06/2023; 12/15/2023; Not provided
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/06/2023; 12/27/2023; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2013
• 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