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

Model Number	100003063
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
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 the procedure, an error message was displayed and the procedure was cancelled.An ensite precision error message appeared on the screen after validation: ¿neck patch disconnected¿.Troubleshooting was performed with no resolution.Af ablation could not be completed and only a cti ablation was performed.The patient was stable with no patient consequences.
Additional Manufacturer Narrative
Additional information: d10, g4, g7, h2, h3, h6, h10 one ensite velocity¿ system navlink was received for investigation.Visual inspection of the internal components revealed an open electrical circuit at the neck patch circuit due to a detached wire, which confirms the reported issue.Based on the information provided to abbott and the investigation performed, the root cause of the error message and subsequent incomplete ablation was isolated to an open electrical circuit within the module.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: ENSITE VELOCITY SYSTEM NAVLINK
• 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: 10296082
• Report Number: 2184149-2020-00103
• Device Sequence Number: 16910444
• Product Code: DQK
• UDI-Device Identifier: 05414734209953
• UDI-Public: 05414734209953
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• 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): 08/24/2020

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: 100003063
• Device Catalogue Number: H420995
• Device Lot Number: 237650001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/24/2020
• 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