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

Model Number 100015555

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: 2184149-2018-00120.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 ensite velocity amplifier was received for analysis.Visual inspection revealed a bent pin on the navlink assembly connector.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.It is undetermined how the physical damage occurred.The cause for the reported communication issue and subsequent procedure cancellation was due to a damaged pin in the navlink assembly connector.

• Brand Name: ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7762036
• MDR Text Key: 116398344
• Report Number: 2184149-2018-00119
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

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
• Device Operator: Health Professional
• Device Model Number: 100015555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 08/13/2018
• Supplement Dates FDA Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ENSITE VELOCITY¿ SYSTEM NAVLINK
• Patient Outcome(s): Other