MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ VELOCITY AMPLIFIER DWS5.1 V.3.0.1.1 SYS; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number	100052451
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2019
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, the ensite system was operating properly until the cryoablation was completed; however, after rf energy was delivered for an atrial flutter using a tacticath catheter and the ampere generator, the ensite dws became disconnected from the amplifier and navigation could not be performed as the 3-d images disappeared.The power socket was changed and the ensite system was power cycled with no resolution.The resume study was unable to be opened.The planned treatment was unable to be completed.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
No product was returned for investigation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott, the reported communication and subsequent cancelation could not be confirmed.

• Brand Name: ENSITE VELOCITY¿ VELOCITY AMPLIFIER DWS5.1 V.3.0.1.1 SYS
• 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: 8957369
• Report Number: 2184149-2019-00155
• Device Sequence Number: 19357780
• Product Code: DQK
• UDI-Device Identifier: 05415067000910
• UDI-Public: 05415067000910
• 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): 11/12/2019

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: 100052451
• Device Catalogue Number: 100052451
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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