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

Model Number GALI 4LV SONR CRT-D 2844

Device Problem Pacing Inadequately (1442)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2024

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.- an ablation by radiofrequency generates electrical current and strong emi - this procedure may cause device damage as described in the manual (see extract below).So in order to protect the device, when strong emi are detected, sensing and pacing are temporary inhibited.Therefore even in voo mode, when strong emi are detected, the icd temporary inhibits pacing."radiofrequency ablation: a radiofrequency ablation procedure in a patient with a generator may cause device malfunction or damage.Rf ablation risks may be minimized by: 1.Deactivating atp and shock therapies.2.Avoiding direct contact between the ablation catheter and the implanted lead or generator.3.Positioning the ground, placing it so that the current pathway does not pass through or near the device, i.E.Place the ground plate under the patient¿s buttocks or legs.4.Having external defibrillation equipment available." - based on the available information, no issue is suspected on the subject pacemaker.

Event Description

Reportedly, during a flutter ablation, the icd didn't pace even in voo mode.

• Brand Name: GALI
• 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 ; 146013665
• MDR Report Key: 18638319
• MDR Text Key: 334677092
• Report Number: 1000165971-2024-00094
• 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
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2024
• Device Model Number: GALI 4LV SONR CRT-D 2844
• Device Catalogue Number: TDF054C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• 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