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

Model Number	100149280
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10179964
• Report Number: 2184149-2020-00085
• Device Sequence Number: 2625447
• Product Code: DQK
• UDI-Device Identifier: 05415067014573
• UDI-Public: 05415067014573
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 100149280
• Device Catalogue Number: 100149280
• Device Lot Number: 5780919
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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