MAUDE Adverse Event Report: MICROPORT CRM S.R.L. GALI DF4 CRT-D 2741; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRON

Model Number GALI DF4 CRT-D 2741

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Atrial Fibrillation (1729)

Event Date 06/13/2022

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, inappropriate atp was delivered to the patient during af.

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.Review of the episodes recorded in the patient files dated on (b)(6) 2022 showed that several treated arrhythmia episodes were recorded.The 2 reported arrythmia episodes, on (b)(6) 2022, were treated by atp.On these 2 episodes, the ventricular rhythm was accelerated < 315ms (314ms on both cases) and stable.Thus, according to the programming, atp was delivered.Based on the available information, the algorithm / icd functioned according to specifications.

Event Description

Reportedly, atp was delivered to the patient during af.

• Brand Name: GALI DF4 CRT-D 2741
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRON
• 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: 14984570
• MDR Text Key: 303646745
• Report Number: 1000165971-2022-00322
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GALI DF4 CRT-D 2741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2022
• 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