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

Model Number	EE3000
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a pulmonary vein contraction procedure, there was a delay of 5 or 6 seconds between catheter movement and its representation in navx.It was questioned whether the memory was full on the cpu so the study was ended, some studies were deleted and the study was resumed again.The issue remained, so it was decided to delete more studies, but then it was note that there were 247 gb free in the cpu, so the cpu and amplifier were restarted which resolved the issue.
Additional Manufacturer Narrative
One ensite velocity¿ system velocity amplifier was received for evaluation.Visual inspection revealed the chassis, connectors and labels appeared to have no physical damage.The amplifier was powered on to a green led status which indicates the power on self-test was successful and communication was established the test station.Review of error logs could not verify any anomaly on the field reported date.Further inspection included successful functional testing of the amplifier.Consistent impedance and current measurements were observed and the patch and navx test was successful.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, the root cause of the reported display issue and subsequent delay remains unknown.

• Brand Name: ENSITE VELOCITY CARDIAC MAPPING SYSTEM
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11820653
• Report Number: 2184149-2021-00138
• Device Sequence Number: 3149196
• Product Code: DQK
• UDI-Device Identifier: 05415067014573
• UDI-Public: 05415067014573
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K160187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: EE3000
• Device Catalogue Number: EE3000
• Device Lot Number: 5064413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1