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

Model Number 100014514

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

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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

During the atypical flutter procedure, self-test issues with the amplifier required multiple troubleshooting measures which resulted in a procedural delay.The amplifier was exchanged and the procedure was completed with no adverse consequences to the patient.The patient was on the table under general anesthesia and catheters were in place, but when the amplifier was turned on, it would not pass the automatic self-test, there was a flashing orange light.The amplifier was turned on and off multiple times without resolution.The delay to the procedure was approximately 2 hours.The amplifier was exchanged and the procedure was completed with no adverse consequences to the patient.

Event Description

Device returned.Updated final report needed to address analysis.

Manufacturer Narrative

One ensite velocity¿ amplifier was received for evaluation at tech center.The reported event was not able to be duplicated.Evaluation testing was successful.Evaluation of the logs revealed no observable symptoms found within the logs.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.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.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.No capa is required; the root cause of the reported issue could not be confirmed to be a manufacturing, design, or quality system related occurrence.The reported issue will continue to be monitored for trends and reviewed in qdr (quality data review).

• Brand Name: ENSITE VELOCITY¿ SYSTEM VELOCITY 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: 18030250
• MDR Text Key: 326859275
• Report Number: 2184149-2023-00212
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141050
• 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,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100014514
• 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: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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