MAUDE Adverse Event Report: MICROPORT CRM S.R.L. GALI 4LV SONR CRT-D 2844; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION

Model Number GALI 4LV SONR CRT-D 2844

Device Problems Connection Problem (2900); Detachment of Device or Device Component (2907); Misassembly by Users (3133)

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

Event Date 05/19/2022

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 atrial connection broke during the implantation.Screwdriver passes through the device.This icd was not used, another icd was implanted.

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.According to the dhr review, the device was manufactured and delivered according to all applicable procedures.

Event Description

Reportedly, the atrial connection broke during the implantation.Screwdriver passes through the device.This icd was not used, another icd was implanted.

Manufacturer Narrative

The manufacturing process for this device was reviewed.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process which might be related to the reported observation.- the returned device analysis revealed the following observations : o atrial connection block was found in an incorrect position o silicone cover on back of atrial connection block is out of the head o regular atrial set screw cavity was found, o the screw was found almost at the middle of the cavity, indicated the lead may not be inserted or totally inserted during screwing o no tightening mark on the atrial set screw tip was found, indicated also the lead was not be inserted or totally inserted during screwing - in the physician manual provided with the device, some recommendations are given on lead connection : 4.Insert the screwdriver into the pre-inserted screw socket of the appropriate port (in order to allow excess air to bleed out and to make the insertion of the lead pin easier).5.Insert the lead pin all the way into the port (check that the pin protrudes beyond the distal connector block).6.Tighten, check the tightness and ensure the lead pin still protrudes beyond the distal connector block, and has not moved - the device has been manufactured and released following all the applicable procedures.- the most probable hypothesis to explain the event is that the atrial lead should not be (fully) inserted during the screwing process and so with excessive force the atrial connection block has been migrated.

Event Description

Reportedly, the atrial connection broke during the implantation.Screwdriver passes through the device.This icd was not used, another icd was implanted.

• Brand Name: GALI 4LV SONR CRT-D 2844
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION
• 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: 14593869
• MDR Text Key: 301022444
• Report Number: 1000165971-2022-00254
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 07/14/2022; 11/24/2022
• Supplement Dates FDA Received: 07/21/2022; 11/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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