MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X EP SYSTEM SURFACELINK MODULE; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number ENSITE-SRFLNK-I-01

Device Problem Material Twisted/Bent (2981)

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

Event Date 10/08/2021

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, validation issues occurred due to an issue with the surface link causing a delay.When the patch was applied and validated, it succeeded, but an alert was issued requesting revalidation.Upon confirmation, the body surface electrocardiogram signal was not output to ensitex.Reconnecting the electrocardiogram cable and system patch, power cycling, and re-pasting the system reference were performed with no resolution.The study was completed using the ensite precision in the hospital as an alternative device.The procedure was delayed by more than 50 minutes.In the verification after the procedure, it was confirmed that the pin of the system reference patch insertion port was scraped.The patch and electrocardiograms were connected to this surface link, but the body surface electrocardiogram was not displayed.When connected to a new alternative surface link, a body surface signal was displayed and was therefore determined that the surface link did not function as expected.

Manufacturer Narrative

Additional information: g3, h2, h3 the results of the investigation are inconclusive since the device was not returned for analysis.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 received and images provided the reported event can be confirmed.

• Brand Name: ENSITE¿ X EP SYSTEM SURFACELINK MODULE
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12618400
• MDR Text Key: 276596283
• Report Number: 2184149-2021-00317
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

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
• Device Model Number: ENSITE-SRFLNK-I-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 11/19/2021
• 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