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 Problem Display or Visual Feedback Problem (1184)

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

Event Date 04/27/2023

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.Investigation outcome: review of provided files confirmed the reported behavior for all three cases: o the last saved lv autothreshold results displayed on the overview screen are not the last measurements performed by the algorithm there is an incoherence in the programming of lv autothreshold and pacing configuration.Pacing configuration is based on v3 vector, whereas lv autothreshold is programmed on lv vector.On the overview screen, the last stored result of lv autothreshold on v3 vector is expect (because of the programming).Due to a known software bug the lv autothreshold on v3 vector is programmed to off, so no automatic update is possible.The episodes and curves from lv autothreshold are coming from test on lv vector (which is programmed to monitor), so based on lv vector.The observed behavior is the result of a known software bug which could occur under the following conditions: following programming is requested by the user: o multipoint lv pacing = off o lv pacing polarity programmed with a ¿v3 pacing chain¿ vector (one of the 6 following configurations: lv3-can, lv3-lv4, lv3-lv2, lv3-rvcoil, lv3-rvring, lv4-rvcoil) o lv autothreshold switched from off to auto or monitor ¿ the programmer programs lv autothreshold as followed: o off on the programmed pacing polarity = the one on ¿v3 pacing chain¿ o auto (resp.Monitor) on a ¿lv pacing chain¿ vector (one of the 8 following configurations: lv1-can, lv1-lv2, lv1-rvcoil, lv1-lv4, lv1-rvring, lv2-can, lv2-rvcoil, lv2-lv4) o the one selected is the last which was programmed (note that as-shipped/default value is lv1-lv2) a software fix is under assessment by microport crm.

Event Description

Reportedly, for these 3 devices, left ventricular auto threshold (lvat) is activated in monitor.On the overview screen of the programmer last lvat value isn't reported whereas there are lvat episodes and curves in aida.

• 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: 17008844
• MDR Text Key: 316886310
• Report Number: 1000165971-2023-00413
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• 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