MAUDE Adverse Event Report: MICROPORT CRM S.R.L. GALI; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number GALI 4LV SONR CRT-D 2844

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Atrial Fibrillation (1729)

Event Date 05/05/2022

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, a patient involved in osiris study and implanted on (b)(6) 2022 with history of atrial fibrillation was admitted to hospital on (b)(6) 2022 after receiving inappropriate shocks.The shocks were due to supraventricular tachycardia conducted to the ventricle at 200 bpm.On (b)(6) 2022, av node ablation was performed and the patient was discharged from hospital on (b)(6) 2022.

Manufacturer Narrative

Analysis of all shock episodes revealed fast ventricular rhythm on the ventricular channel.The ventricular rate exceeded the fast vt zone threshold.However, this fast ventricular rhythm was most probably induced by the initial atrial fibrillation.As expected in the fast vt zone, atp was applied after the persistence was reached.The delivery of atp might have induced a fast ventricular tachycardia, and a second vf majority was reached, leading to a shock delivery.Based on available data, normal functioning of the device occurred.No anomaly is suspected on the subject: (b)(4).

Event Description

Reportedly, a patient involved in osiris study and implanted on (b)(6) 2022 with history of atrial fibrillation was admitted to hospital on (b)(6) 2022 after receiving inappropriate shocks.The shocks were due to supraventricular tachycardia conducted to the ventricle at 200 bpm.On (b)(6) 2022, av node ablation was performed and the patient was discharged from hospital on (b)(6) 2022.

• Brand Name: GALI
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• 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: 14683678
• MDR Text Key: 301256307
• Report Number: 1000165971-2022-00276
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Catalogue Number: GALI 4LV SONR CRT-D 2844
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 08/19/2022
• 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