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

Model Number GALI DF4 SONR CRT-D 2841

Device Problem Premature Discharge of Battery (1057)

Patient Problems Dyspnea (1816); Fatigue (1849)

Event Date 10/21/2022

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, (b)(6) 2022 the subject device was explanted due to premature depletion with absence of output (ecg revealed the device was not pacing).By trying to interrogate the device, no led was on.

Event Description

Reportedly, on (b)(6) 2022 the subject device was explanted due to premature depletion with absence of output (ecg revealed the device was not pacing).By trying to interrogate the device, no led was on.

Manufacturer Narrative

Please refer to the updated analysis report.

• Brand Name: GALI DF4 SONR CRT-D 2841
• 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: 15788103
• MDR Text Key: 303903912
• Report Number: 1000165971-2022-00512
• 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: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

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 Model Number: GALI DF4 SONR CRT-D 2841
• 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: 10/28/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 01/12/2023
• 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