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 Problems Decoupling (1145); Connection Problem (2900)

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

Event Date 07/10/2023

Event Type  malfunction  

Event Description

Reportedly, at the icd's implantation, the physician has correctly inserted the atrial and the ventricular leads.He has noticed an atrial connector dislodgment during the screwing.He has repositioned the connector.A parameters check has been performed (impedance, threshold (sensing and pacing) several times and everything was correct.Therefore, the device has been implanted but he wants to verify whether or not no issue could occur due to this issue, the root cause.The patient will be followed thanks to remote monitoring.

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, at the icd's implantation, the physician has correctly inserted the atrial and the ventricular leads.He has noticed an atrial connector dislodgment.During the screwing.He has repositioned the connector.A parameters check has been performed (impedance, threshold (sensing and pacing) several times and everything was correct.Therefore, the device has been implanted but he wants to verify whether or not no issue could occur due to this issue, the root cause.The patient will be followed thanks to remote monitoring.

Manufacturer Narrative

- the device has been manufactured and released following all the applicable procedures.- the retention force of the atrial connection block could have initially been within specification (= 17 n) but probably with an excessive thrust force (> 20n) the connection block has dislodged.- in the physician manual provided with the device, it is specified that the screwdriver¿s hexagonal tip should be pushed smoothly into the set-screw cavity until it reaches the bottom of the cavity.When the bottom is reached, there will be a ¿hard stop¿ with metal on metal contact.Please refer to the attached analysis report.

• 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: 17486424
• MDR Text Key: 321647767
• Report Number: 1000165971-2023-00596
• 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: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2023
• 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