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

Model Number GALI 4LV SONR CRT-D 2844

Device Problems Failure to Deliver Shock/Stimulation (1133); Connection Problem (2900)

Patient Problem Electric Shock (2554)

Event Date 08/22/2023

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, on the device of the case report c-3351, on tuesday (b)(6), our sales representative performed a synchronous 42j shock to reinitialize the shock impedance and to reduce the patient's on going atrial fibrillation.The charge went well but the shock is 0,7j and 14000ohm (all other lead parameters are ok and were tested just before the shock).She launched a second shock and got the same results.An external shock has been delivered to reduce the atrial fibrillation.The files are available.The heath care team and our sales rep suspect that the connector has been damaged when the icd lead was replaced on (b)(6) 2022 or that the leads could be in contact? the device will be replaced (the date is not yet known) and she will ask for a shock delivery when the device is replaced to be sure that there is not short circuit between the leads.

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.Suspected issue on the igbt semi conductors.Shocks cannot be delivered.Final report and explanations in the next mdr.

Event Description

Reportedly, on the device of the case report c-3351, on tuesday 22nd of august, our sales representative performed a synchronous 42j shock to reinitialize the shock impedance and to reduce the patient's on going atrial fibrillation.The charge went well but the shock is 0,7j and 14000ohm (all other lead parameters are ok and were tested just before the shock).She launched a second shock and got the same results.An external shock has been delivered to reduce the atrial fibrillation.The files are available.The heath care team and our sales rep suspect that the connector has been damaged when the icd lead was replaced on december 15, 2022 or that the leads could be in contact ? the device will be replaced (the date is not yet known) and she will ask for a shock delivery when the device is replaced to be sure that there is not short circuit between the leads.

Manufacturer Narrative

He investigation on the returned device revealed upon reception of the subject device, - the connector was partially detached from the surrounding casing.The rv and svc continuity measurements remain in the normal range.Therefore the partially detached connector is probably not the origin of the high shock impedance.- damage of low and high circuits on the can and the rv shock electrode of the can.The integrated circuit (ic), at the level of the circuits driving the shock delivery are damaged leading to high shock impedance and impossibility to deliver the energy stored by the capacitors.The analysis of the provided data highlighted that the energy stored for shocks to revert atrial fibrillation on (b)(6) 2022 was not delivered and that the shock impedance was still very high.The previous icd lead, when damaged led to 1143 shocks in 2 days ((b)(6) 2023).During the shocks the device can, and the damaged lead may have been in contact leading to short circuit and the definitive damage of the integrated circuit (ic), at the level of the circuits driving the shock delivery.The damage of the integrated circuit (ic) triggers the impossibility to deliver the energy stored by the capacitors.The failure may be linked to the high number of inappropriate shocks delivered when the icd lead was damaged.The icd lead had been replaced on (b)(6) 2022.The subject device has been replaced on (b)(6) 2023 and all electrical measurements combining the new icd lead ((b)(6) 2022) and the new device ((b)(6) 2023) were good on the day of the device replacement.This case is retained and utilized for trend purposes.

Event Description

Reportedly, on the device of the case report c-3351, on tuesday (b)(6), our sales representative performed a synchronous 42j shock to reinitialize the shock impedance and to reduce the patient's on going atrial fibrillation.The charge went well but the shock is 0,7j and 14000ohm (all other lead parameters are ok and were tested just before the shock).She launched a second shock and got the same results.An external shock has been delivered to reduce the atrial fibrillation.The files are available.The heath care team and our sales rep suspect that the connector has been damaged when the icd lead was replaced on (b)(6) 2022 or that the leads could be in contact ? the device will be replaced (the date is not yet known) and she will ask for a shock delivery when the device is replaced to be sure that there is not short circuit between the leads.

• Brand Name: GALI
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATI
• 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: 17779371
• MDR Text Key: 323801037
• Report Number: 1000165971-2023-00742
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2023

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 Expiration Date: 03/21/2024
• Device Model Number: GALI 4LV SONR CRT-D 2844
• Device Catalogue Number: TDF054C
• 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: 08/25/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 10/17/2023; 11/13/2023
• Supplement Dates FDA Received: 11/15/2023; 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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