MAUDE Adverse Event Report: MICROPORT CRM S.R.L. GALI; DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)

Model Number GALI 4LV SONR CRT-D 2844

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Atrial Fibrillation (1729); Chest Pain (1776)

Event Date 09/08/2022

Event Type  malfunction  

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, the patient received inappropriate atp and shock due to atrial fibrillation.

Manufacturer Narrative

Review of the episodes recorded in the device memory showed (last data files dated of 08 september 2022) that : - all the episodes recorded in the device memory since (b)(6) 2022 showed physiological signals.- 2 atp then one shock therapies were delivered (as programmed) for an accelerated ventricular rhythm (> 185bpm) that was classified as a vt episode on (b)(6) 2022 at 09:02.The most probable hypothesis to explain the discrimination of an atrial fibrillation as a ventricular tachycardia is that long cycles were not detected as the programmed long cycle gap was too long.- based on available data, the crt-d operated as programmed and as specified.- no issue is suspected on the subject crt-d.

Event Description

Reportedly, the patient received inappropriate atp and shock due to atrial fibrillation.

• Brand Name: GALI
• Type of Device: DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• MDR Report Key: 15743959
• MDR Text Key: 303909707
• Report Number: 1000165971-2022-00489
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GALI 4LV SONR CRT-D 2844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic