MAUDE Adverse Event Report: MICROPORT CRM S.R.L. GALI 4LV SONR CRT-D 2844; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number GALI 4LV SONR CRT-D 2844

Device Problems Display or Visual Feedback Problem (1184); Patient Data Problem (3197)

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

Event Date 11/28/2022

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, an icd (gali 4lv sonr crt-d 2844 s/n (b)(4)) was implanted on (b)(4) 2022 without problems, the parameters were programmed and the patient and leads data were entered.The session was closed and the icd was interrogated again and a message appears indicating that the patient data is missing, and when checking it all the fields are empty.

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.H11.Corrected data: g3.3.Date received by manufacturer changed to 17/01/2023 as final software analysis received.

Event Description

Reportedly, an icd (gali 4lv sonr crt-d 2844 s/n: (b)(6) was implanted on (b)(6) 2022 without problems, the parameters were programmed and the patient and leads data were entered.The session was closed and the icd was interrogated again and a message appears indicating that the patient data is missing, and when checking it all the fields are empty.

• Brand Name: GALI 4LV SONR CRT-D 2844
• 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: 16002490
• MDR Text Key: 305846128
• Report Number: 1000165971-2022-00591
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2023
• 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