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

Model Number PLATINIUM 4LV CRT-D 1744

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 01/05/2024

Event Type  malfunction  

Event Description

Reportedly, on (b)(6) 2024,platinum 4lv crt-d 1744 (s/n:(b)(6)) was implanted.On (b)(6) 2024, we received a telephone inquiry from medical staff."it was observed that the intracardiac potentials and markers of the rms real-time electrocardiogram are misaligned, is this linked to the display?".

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, on 2024-01-05,platinium 4lv crt-d 1744 (s/n:(b)(6) was implanted.On (b)(6) 2024, we received a telephone inquiry from medical staff."it was observed that the intracardiac potentials and markers of the rms real-time electrocardiogram are misaligned, is this linked to the display?".

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.A display issue is suspected.Therefore, no issue is suspected on the subject device.Since no expertise files concerning the reported issue could be provided, the reported event could neither be confirmed nor investigated.The case is therefore closed as is and will be reopened should any new relevant information be provided in the future.This case is retained and utilized for trend purposes.

• Brand Name: PLATINIUM
• 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: 18604681
• MDR Text Key: 335092639
• Report Number: 1000165971-2024-00082
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527015446
• UDI-Public: (01)08031527015446(17)061124(11)110522
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PLATINIUM 4LV CRT-D 1744
• Device Catalogue Number: TDF039J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• 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