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

Device Problems Communication or Transmission Problem (2896); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  malfunction  

Event Description

The site noted that the navlink had a broken; missing a pin at the neck patch connector and the case was cancelled.Per the tech support sheets, the system allowed validation without patches connected to the navlink and no errors were noted when the patches were disconnected from navlink.It¿s possible there was no location on at this time early in the study, but given thenavlink had damaged pins, it was advised that the system was inoperable until it was replaced.

Event Description

Add info: the physician proceeded with the case without mapping and chose to use fluoroscopy and intracardiac echo to guide his ablation.The procedure was completed that day without use of the ensite precision mapping system.

Manufacturer Narrative

Correction: h6 health effect code additional info: b5, d9, g3, h2, h3.One ensite velocity¿ navlink module was received for analysis.Visual inspection revealed signs of wear consistent with clinical use.It was observed that the 1-64 channel connector locking ring was fractured.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information provided to abbott and the investigation performed, the root cause of the reported event has been isolated to physical damage to the 1-64 channel connector end.

Manufacturer Narrative

Additional information: d9, g3, h2, h3.One ensite velocity¿ navlink module was received for analysis.Visual inspection revealed signs of wear consistent with clinical use.It was observed there was a broken/missing pin at the neck patch connector, confirming the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information provided to abbott and the investigation performed, the root cause of the reported event has been isolated to physical damage to the neck patch connector.

Event Description

The physician proceeded with the case without mapping and chose to use fluoroscopy and intracardiac echo to guide his ablation.The procedure was completed that day without use of the ensite precision mapping system.

• Brand Name: ENSITE VELOCITY¿ SYSTEM NAVLINK
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17218416
• MDR Text Key: 318027882
• Report Number: 2184149-2023-00127
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 07/19/2023; 07/19/2023
• Supplement Dates FDA Received: 07/19/2023; 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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