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 Loose or Intermittent Connection (1371); Material Rupture (1546); Detachment of Device or Device Component (2907)

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

Event Date 03/31/2022

Event Type  malfunction  

Event Description

During the left ventricular lead replacement, following its dislodgement, the atrial lead could not be screwed correctly.Indeed, once the physician placed the screwer in front of the screw head of the atrial lead, the whole lodgement completely went out of the head of the defibrillator on the opposite side;.

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.The center has reported to the local authority on 31/03/2023 and the corresponding complaint has been opened on 24/01/2024.The atrial connector has been detached after the screwing.There is no patient risk associated.The only risk is a discomfort.

Manufacturer Narrative

The conclusions are as follows: the device has been manufactured and released following all the applicable procedures.A likely hypothesis is that the retention force of the atrial connection block could have initially been within specification (= 17 n) but probably with an excessive thrust force (> 38.5 n) the connection block has dislodged during the lead connection.A second hypothesis would be that the lead was not fully inserted before screwing.For more details, please refer to the attached analysis report.

Event Description

During the left ventricular lead replacement, following its dislodgement, the atrial lead could not be screwed correctly.Indeed, once the physician placed the screwer in front of the screw head of the atrial lead, the whole lodgement completely went out of the head of the defibrillator on the opposite side;.

• 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 ; 146013665
• MDR Report Key: 18757467
• MDR Text Key: 335992420
• Report Number: 1000165971-2024-00168
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527018577
• UDI-Public: (01)08031527018577(17)100624(11)101221
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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: TDF054C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2021
• 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