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

Model Number	H420995
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During an ablation procedure, the 3d navigation did not function as expected.Troubleshooting was attempted by repositioning patches, revalidating, and restarting the computer and amplifier, with no resolution.Exchaning the navlink resolved the issue and the procedure was continued with no consequences to the patient.The length of procedure was extended by an hour and was clinically significant due to increased heparin administration and difficulties in managing sedation for the patient.
Additional Manufacturer Narrative
One ensite velocity¿ navlink module was received for investigation.Visual inspection of the returned product confirmed all input and output connectors were free of physical damage.Functional testing performed verified circuit integrity on all channels during the evaluation period.Based on the information provided to abbott and the investigation performed, the root cause of the reported display issue and subsequent delay in procedure cannot be conclusively determined as no abnormalities were identified.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: ENSITE VELOCITY¿ NAVLINK MODULE
• 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: 9279383
• Report Number: 2184149-2019-00212
• Device Sequence Number: 2388244
• Product Code: DQK
• UDI-Device Identifier: 05414734209953
• UDI-Public: 05414734209953
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K160187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H420995
• Device Lot Number: 524700002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other