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

Model Number ENSITE-SRFLNK-I-01

Device Problem Impedance Problem (2950)

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

Event Date 11/22/2021

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, the physician alleged a clinically significant delay occurred due to an impedance system error.The rl electrode was disconnected to resolve the issue and the procedure was completed.There were no adverse consequences to the patient.

Manufacturer Narrative

One ensite x surfacelink module (pn 600100526 sn (b)(6)) was received for evaluation.Visual inspection revealed the exterior casing, labels, and electrical pins were free of physical damage.The cable insulation was intact, and the connector was free of physical damage.The module was recognized upon connecting to a test station.A continuity test was performed, and it was verified all surfacelink electrical pins operated as intended with no issues.A simulated electro-cardiogram (ecg) signal was connected to the module and consistent ecg signals were observed on the test station.The field reported event was not confirmed.Functional testing was successful during the evaluation.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 remained undetermined as the field reported event was not reproducible.

• Brand Name: ENSITE¿ X EP SYSTEM SURFACELINK MODULE
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12882069
• MDR Text Key: 281319146
• Report Number: 2184149-2021-00384
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• 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
• Device Lot Number: 802840001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2021
• 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