MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ VELOCITY¿; 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	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One ensite velocity¿ amplifier was received for evaluation.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 a voltage out of range condition during post for catheter amplifier board in slot 9.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.
Event or Problem Description
During the atrial fibrillation procedure, self-test failure issues with the amplifier required multiple troubleshooting measures which did not resolve the issue and the procedure was cancelled.It was noted that the amplifier booted up and connected to the dws without issue, however, after a few moments, the amplifier status light went to solid amber.The amplifier was rebooted several times, all connections were unplugged, the power was unplugged and let sit for a minute all without resolution.Rebooted again to solid amber and it remained solid amber.The case was cancelled with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d1, d4, g3, h2, h11.
Additional Manufacturer Narrative
Udi related data quality updates only.Additional information: d1, d4, g3, h2, h11.

• Brand Name: ENSITE¿ VELOCITY¿
• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18357998
• Report Number: 2184149-2023-00243
• Device Sequence Number: 6398753
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: (01)05414734210713(21)18983993(10)7946635
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K201181
• 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): 07/22/2024

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
• Device Lot Number: 7946635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 06/10/2024; 07/09/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 06/20/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• 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