MAUDE Adverse Event Report: ST. JUDE MEDICAL AMPERE¿ RF ABLATION GENERATOR; EP GENERATOR

Model Number H700495

Device Problems Failure to Deliver Energy (1211); Low impedance (2285)

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

Event Date 08/03/2021

Event Type  malfunction  

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.Based on the information received and electronic data, the reported incident is not verified to have occurred.The cause could not be determined. .

Event Description

During a supraventricular tachycardia (svt) ablation procedure, the power stayed at 0w.The cool point pump was successfully connected.The catheter was exchanged and cable were exchanged, but the issue persisted.The generator was replaced with an ampere and the procedure was able to be completed with no adverse patient consequences.

Manufacturer Narrative

Following field service, it was determined that the reported event was related to a software anomaly.After service, the generator functioned as normal with no issues and the issue was resolved.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received the cause for the reported incident could not be determined. .

Manufacturer Narrative

Review of the provided field service report found the field technician was unable to reproduce the reported event.The system log files were retrieved for analysis.Review of the provided log files confirmed a lag processing error on the reported event date, confirming the reported event.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 is consistent with a software anomaly.

• Brand Name: AMPERE¿ RF ABLATION GENERATOR
• Type of Device: EP GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12361565
• MDR Text Key: 267951513
• Report Number: 2030404-2021-00049
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P110016
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H700495
• Device Lot Number: 7059780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2019
• 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