MAUDE Adverse Event Report: MICROPORT CRM S.R.L. GALI DF4 SONR CRT-D 2841; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRON

Model Number GALI DF4 SONR CRT-D 2841

Device Problems Display or Visual Feedback Problem (1184); Data Problem (3196)

Patient Problem Syncope/Fainting (4411)

Event Date 08/02/2022

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, the defibrillator concerned by this issue is a gali defibrillator implanted with a bipolar epicardial lv lead and ra and rv plugs.During a follow-up pre-implantation of the missing leads, a lv threshold test was performed but it was impossible to visualize the associated egm.Therefore an external ecg was used to confirm the capture and threshold value.During the following days, the patients reported syncopes mostly nocturnal.The output values was badly set and was lower than necessary given the new threshold tests since there was an increase of threshold.While only the left lead was implanted, the physician performed the automatic test of the lv threshold in vvi.An egm was displayed, whereas when selecting the egm channel, lv could not be selected; only the options "ecg, egm a, egm rv, coil rv-can" were displayed.When the threshold test was manual, no egm signal was displayed.On 2 august 2022, the right ventricular and atrial leads were implanted.

Manufacturer Narrative

Analysis revealed that the observed issue with the absence of the lv egm during the lv threshold is within specifications.This is because no lv egm is available on the programmer threshold test screen.It should be noted that the rv coil-can egm is only available on the programmer screen in the case of automatic threshold test and not in manual test.During further investigation, the reported behavior could be reproduced in laboratory: a signal is present on the right ventricular (rv) coil-can egm despite the absence of the rv lead.If the rv coil electrode input is high impedance (which is the case in absence of an implanted rv lead), the signal on the lv pacing with an amplitude of a few volts may induce crosstalk due to internal coupling, mainly in unipolar configuration.As the left ventricular automatic threshold (lvat) is based on a combined analysis of two fixed egm signals which are analyzed after lv pacing (rv coil-can egm and bipolar rv egm), a functional rv lead is required.Based on available data, no anomaly is suspected on the subject device.However, it should be noted that a threshold obtained by automatic lvat could not be reliable in absence of an rv lead.

Event Description

Reportedly, the defibrillator concerned by this issue is a gali defibrillator implanted with a bipolar epicardial lv lead and ra and rv plugs.During a follow-up pre-implantation of the missing leads, a lv threshold test was performed but it was impossible to visualize the associated egm.Therefore an external ecg was used to confirm the capture and threshold value.During the following days, the patients reported syncopes mostly noctural.The output values was badly set and was lower than necessary given the new threshold tests since there was an increase of threshold.While only the left lead was implanted, the physician performed the automatic test of the lv threshold in vvi.An egm was displayed, whereas when selecting the egm channel, lv could not be selected; only the options "ecg, egm a, egm rv, coil rv-can" were displayed.When the threshold test was manual, no egm signal was displayed.On (b)(6) 2022, the right ventricular and atrial leads were implanted.

• Brand Name: GALI DF4 SONR CRT-D 2841
• 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
• MDR Report Key: 15333592
• MDR Text Key: 304964399
• Report Number: 1000165971-2022-00392
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

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 DF4 SONR CRT-D 2841
• Device Catalogue Number: GALI DF4 SONR CRT-D 2841
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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