MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY SYSTEM MEDIA CONVERTER; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number 100149280

Device Problem Application Program Problem (2880)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .

Event Description

During the procedure, sluggish performance of catheter movement resulting in a 7 second delay was noted.This issue occurred sporadically throughout the procedure resulting in a clinically significant delay in procedure.There no adverse consequences to the patient due to the delay.

Manufacturer Narrative

Additional information: b5, d1, d2, g4, g7, h2, h3, h6, h10.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported sluggish performance and subsequent delay remains unknown, but was resolved after replacing the media converter.

Event Description

During the procedure, sluggish performance of catheter movement was noted with an approximate 7 second delay.This issue occurred sporadically throughout the procedure resulting in a clinically significant delay in procedure.There were no adverse consequences to the patient due to the delay.Further troubleshooting was performed, and once the media converter was replaced it resolved the sluggish performance.

• Brand Name: ENSITE VELOCITY SYSTEM MEDIA CONVERTER
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10179964
• MDR Text Key: 195959593
• Report Number: 2184149-2020-00085
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067014573
• UDI-Public: 05415067014573
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100149280
• Device Catalogue Number: 100149280
• Device Lot Number: 5780919
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other