MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE X EP SYSTEM AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-AMP-02

Device Problem Output Problem (3005)

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

Event Date 10/17/2022

Event Type  malfunction  

Event Description

During a redo pulmonary vein isolation procedure, an output issue occurred and the case was cancelled with no consequences to the patient.When creating the study, no ecg signals were displayed in the dws and an error message was noted stating: "amplifier-error" and the light of the amplifier flashed orange.As a result, only the amplifier was restarted as described in the error message.However, the error persisted.A connection error from the dws to the amplifier could be excluded, as signals were displayed in the ep system, which are only passed through the amplifier.As a next step, the amplifier and dws were used together and also individually several times (7 times), as well as disconnecting the power connection to the amplifier several times.The amplifier and dws were drained from power for 45 minutes, and then tried again to start the dws with amplifier and disconnected all the cables on the front panel.Then everything functioned properly, connection to dws, green light on the amplifier and ecg signals in the dws.The patient status was stable, but the procedure was cancelled.

Manufacturer Narrative

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, the cause of the reported output issue and cancellation remain unknown.

Manufacturer Narrative

One ensite x amplifier was received for evaluation.Functional testing which includes power cycling, extended run, test station log review, and ic shorts testing, all of which encountered no hardware abnormalities.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 not able to be confirmed, and the root cause remains undetermined.

• Brand Name: ENSITE X EP SYSTEM AMPLIFIER
• 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: 15666140
• MDR Text Key: 305610036
• Report Number: 2184149-2022-00256
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: 05415067034755
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-AMP-02
• Device Catalogue Number: ENSITE-AMP-02
• Device Lot Number: 8482598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2022
• 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