MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY NAVLINK MODULE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H420995
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2020
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 an atrial fibrillation and atrioventricular nodal re-entrant tachycardia (avnrt) ablation procedure, the navlink pin detached within the patch connector and mapping was no longer possible.The avnrt ablation was completed without mapping, however the atrial fibrillation portion of the procedure was unable to be completed and the procedure was cancelled.There were no adverse consequences to the patient due to the cancellation.
Additional Manufacturer Narrative
Additional information: d10, g4, g7, h2, h3, h6, h10.One ensite velocity¿ navlink module was returned for investigation.Inspection of the input and output connectors revealed the ¿neck¿ patch electrical contact pin has broken off and was not returned.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information provided to abbott and the investigation performed, the root cause of the event was isolated to a broken electrical contact pin.The cause of the detached pin remains unknown.

• Brand Name: ENSITE VELOCITY NAVLINK MODULE
• 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: 10220707
• Report Number: 2184149-2020-00094
• Device Sequence Number: 19434044
• Product Code: DQK
• UDI-Device Identifier: 05414734209953
• UDI-Public: 05414734209953
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 07/22/2020

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: H420995
• Device Catalogue Number: H420995
• Device Lot Number: 263160004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/22/2020
• 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