MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ EPT GENCONNECT KIT; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number	100011879
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer report number: 2184149-2018-00158, 9680001-2018-00139, 9680001-2018-00140.During an atrial flutter ablation procedure, there was noise on signals 1 and 2 of the workmate system and those signals didn't display on the ensite system.The impedance value remained at 999 ohms and wouldn't communicate with the tactisys quartz.The catheter was replaced and functioned as intended initially, but after a series of ablations communication was lost.The tactisys was power cycled several times and communication was restored.After three more ablations a steam pop occurred.The catheter was replaced to a non-abbott catheter with a non-abbott generator.Prior to inserting the catheter, the temperature was confirmed to be high.It was replaced again but the issue remained, so the procedure was cancelled.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
The results of the investigation are inconclusive as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.The device history record was unable to be reviewed as the lot number was unavailable.

• Brand Name: ENSITE VELOCITY¿ EPT GENCONNECT KIT
• 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: 7899409
• Report Number: 2184149-2018-00159
• Device Sequence Number: 1551884
• Product Code: DQK
• UDI-Device Identifier: 05414734210546
• UDI-Public: 05414734210546
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/28/2018

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: 100011879
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 11/28/2018
• 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