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

Model Number ENSITE-AMP-02

Device Problem Failure of Device to Self-Test (2937)

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

Event Date 02/08/2023

Event Type  malfunction  

Event Description

During system preparation both the system and the amplifier had to be rebooted 8 times following the correct sequence of power up from ifu.Twice, the system recognized the connection but only for a few seconds, then resumed with the amplifier amber flashing light.The patient had been patched at this point.

Manufacturer Narrative

One ensite x amplifier was received.The field reported event was not able to be duplicated, however the logs identified a slot 4 pmbus condition which confirmed a sudden loss of communications and a pmbus condition which could cause a post condition.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 cardiamp board in slot 4.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported self-test issue were identified.

Event Description

During system preparation for a ventricular tachycardia procedure, both the system and the amplifier had to be rebooted 8 times following the correct sequence of power up from the ifu resulting in a delay of procedure.Twice, the system recognized the connection but only for a few seconds, then resumed with the amplifier amber flashing light.The patient had been patched at this point.The device was replaced with a carto system and the issue was resolved with no adverse consequences.

• Brand Name: ENSITE X EP SYSTEM AMPLIFIER
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 16405915
• MDR Text Key: 309903807
• Report Number: 2184149-2023-00044
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: 05415067034755
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• 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: 8164090
• 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: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• 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