MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ NAVLINK MODULE; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number	H420995
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 incident could not be conclusively determined.A review of inspection results for this lot number confirmed that no non-conformances were identified related to the reported event and the product met abbott specifications.
Event or Problem Description
During an atrial fibrillation ablation procedure a cancellation occurred due to an error message.Following anesthesia and sheath insertion, the system reference patches were placed on the patient.Three errors were displayed upon patch placement and could not be resolved even after the patches were exchanged.The procedure was cancelled with no adverse consequences onto the patient.

• Brand Name: ENSITE VELOCITY¿ NAVLINK MODULE
• 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: 7698177
• Report Number: 2184149-2018-00109
• Device Sequence Number: 1753811
• Product Code: DQK
• UDI-Device Identifier: 05414734209953
• UDI-Public: 05414734209953
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K160187
• 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
• Report Date (Section B): 07/18/2018

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: H420995
• Device Lot Number: 511450001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/18/2018
• 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
• Patient Age: 72 YR
• Patient Weight: 113