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

Model Number ENSITE-R-AMP-02

Device Problem Communication or Transmission Problem (2896)

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

Event Date 03/27/2023

Event Type  malfunction  

Event Description

During a premature ventricular vein contraction procedure, a communication issue occurred and the case was cancelled.The ablation signals were not visible on the amplifier (signals were visible on the workmate system).The generator was replaced, the cables between the generator and amplifier were replaced, the amplifier/computer/ampere were turned off and on and the catheter was exchanged twice which did not resolve the issue and the procedure was cancelled.

Manufacturer Narrative

One ensite x amplifier was received for evaluation.Visual inspection revealed the rear ports and chassis show signs of wear consistent with use over time.Visual inspection of the front panel ports revealed a bent pin in port 5.The amplifier was powered on and then the amplifier booted to a solid green ¿ready¿ light emitting diode (led) status.This indicated the amplifier passed the power-on-self-test (post) and then successfully communicated with the test station tracker software.The intra-cardiac (ic) short test was partially run and revealed that the ablation connector port was loose in the front panel and could be rotated; it would intermittently function.The field reported event was able to be duplicated by ic short test and catheter communication testing.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 reported event was able to be confirmed, and the root cause was attributed to physical damage to the ablation port to the front plane connection.

• Brand Name: ENSITE X EP SYSTEM 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16622305
• MDR Text Key: 312070893
• Report Number: 2184149-2023-00069
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067034748
• UDI-Public: 05415067034748
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-R-AMP-02
• Device Catalogue Number: ENSITE-R-AMP-02
• Device Lot Number: 8253802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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