MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ VELOCITY NAVX PATCH KIT; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	100003331
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2019
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
Related manufacturing ref: 2184149-2019-00153.During a pulmonary vein isolation procedure, the tactisys would not connect and the procedure was significantly delayed.After validation, the light on the tactisys was amber colored and the system stated, "searching for tactisys." the light would not turn green so the tactisys was restarted and the network cables were verified with no resolution.The ethernet cable was replaced and ensite was restarted with no resolution.The case was closed out and resume study and revalidation of the patches was not possible.The error message "navx validation failed.The data module is intended for single use only" displayed.After 30 minutes of troubleshooting, the procedure was continued with a different catheter.The procedure was completed successfully.There were no adverse consequences to the patient due to the delay.
Additional Manufacturer Narrative
Additional information: the reported recognition issue was not confirmed.The patches displayed continuity with no open circuits detected.In addition, the leg patch was able to be validated with no anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported recognition issue and subsequent procedure delay remains unknown.

• Brand Name: ENSITE VELOCITY¿ VELOCITY NAVX PATCH KIT
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8932316
• Report Number: 2184149-2019-00154
• Device Sequence Number: 13960294
• Product Code: DQK
• UDI-Device Identifier: 05414734210003
• UDI-Public: 05414734210003
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K083328
• 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): 09/23/2019

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 Expiration Date: 07/22/2020
• Device Model Number: 100003331
• Device Lot Number: 904602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TACTISYS¿ QUARTZ ABLATION SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Weight: 85