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

Model Number 100003063

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in a subsequent submission.

Event Description

When starting the case, the connector of the navlink was broken and the case was cancelled.Attempts to connect it were unsuccessful and the case was rescheduled.

Manufacturer Narrative

One ensite velocity¿ system navlink was received for evaluation.Visual inspection revealed physical damage to the green connectors.Connection could not be established and the connector was noted to be loose.Further inspection verified normal wear and tear observed on the chassis and the wire insulation was fully intact.The root cause was isolated to physical damage due to an undetermined event.

• Brand Name: ENSITE VELOCITY SYSTEM NAVLINK
• 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: 9717637
• MDR Text Key: 181184551
• Report Number: 2184149-2020-00024
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K172396
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100003063
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other