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

Model Number 100003063

Device Problem Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2018

Event Type  Injury  

Event Description

Related manufacturing ref: 2184149-2018-00119.During preparation for an electrophysiology procedure, the system could not locate the neck patch even though it was properly connected and applied to the patient.Rebooting the systems and using different patches did not resolve the issue.A replacement navlink was obtained which did not resolve the issue.The connection between the navlink and the amplifier was inspected which revealed a bent pin and a missing part was noted in the jack of the amplifier.The procedure was stopped with no harm to the patient.

Manufacturer Narrative

One navlink module was received for evaluation.Visual inspection revealed no anomalies.The returned product functioned properly during the evaluation.No hardware abnormalities that would have resulted in the reported event were identified.A review of inspection results for this lot number confirmed the product was manufactured according to specifications.Based on the information provided to abbott and the investigation performed, the reported event was unable to be confirmed.

• Brand Name: ENSITE VELOCITY¿ SYSTEM NAVLINK
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 7762020
• MDR Text Key: 116398234
• Report Number: 2184149-2018-00120
• Device Sequence Number: 1
• Product Code: DQK
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100003063
• Device Lot Number: 430690001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER; ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER
• Patient Outcome(s): Other