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

Model Number H420995

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .

Event 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.

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
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10220707
• MDR Text Key: 197382797
• Report Number: 2184149-2020-00094
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734209953
• UDI-Public: 05414734209953
• Combination Product (y/n): N
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other