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

Model Number ENSITE-R-AMP-02

Device Problems Communication or Transmission Problem (2896); Output Problem (3005)

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

Event Date 12/28/2022

Event Type  malfunction  

Event Description

During a vt ablation procedure, the ensite x amplifier disconnected and gave an error message resulting in multiple restarts of the amplifier causing procedural delays.At the beginning of the case, an error message was displayed prompting to restart the amplifier.The amplifier was restarted once at the beginning of the case prior to catheters being placed with all external connections intact and the amplifier status indicator flashed amber.Then it was restarted once again with all external connections removed.At this point the amplifier status light turned green and the case continued.Then, in the middle of the case, the amplifier was restarted twice without external connections but the status light remained flashing amber each time.With multiple restarts, the amplifier was never able to be reconnected.The same error was called in to tech services last week and were told to disconnect all cabling and restart the amplifier and that "nothing was wrong with the amplifier." now, it was felt there was an issue with the amplifier as it was necessary to re-install precision in order to complete the case.The amplifier was restarted a total of 4 times.The procedure was successfully completed with no adverse consequences to the patient.However, most of the therapeutic portion of the procedure was done without 3d mapping support of any kind due to the amplifier not working.

Manufacturer Narrative

One ensite x amplifier, ensite-r-amp-02 was received into the lab for analysis.The returned product functioned properly throughout the product evaluation, no errors or loss of communication were noted.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 the investigation performed, the cause for the reported event was unable to be determined.The returned product functioned properly during the evaluation.No hardware abnormalities that would have resulted in the reported event were identified.

• 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: 16204375
• MDR Text Key: 307718898
• Report Number: 2184149-2023-00011
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067034748
• UDI-Public: 05415067034748
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2023

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
• Device Model Number: ENSITE-R-AMP-02
• Device Catalogue Number: ENSITE-R-AMP-02
• Device Lot Number: 8785733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2022
• 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