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

Model Number H420995

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event 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.

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
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9279383
• MDR Text Key: 165081052
• Report Number: 2184149-2019-00212
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734209953
• UDI-Public: 05414734209953
• Combination Product (y/n): N
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other