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

Model Number PLATINIUM SONR CRT-D 1811

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 01/19/2024

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.The conclusions are as follows: this event is due to a bug where the ventricular fibrillation episode is incorrectly recorded inducing no associated egm and marker chains are loaded from the aida memories.This issue will be corrected on the next platinium version (v4.04).Nevertheless, the episode can be retrieved by the corresponding team but only in case there was no memories¿ reset.

Event Description

The physician interrogated the device and a delivered shock appeared at the overview (with warning) of the orchestra+ programmer but there was no episode in the episode list bolonging to this shock.After several tries of interrogation and the attempt with a smarttouch programmer we recognized that in the (on the o+) saved episodes list there is the episode listed, but with no data (iegm) inside.

• 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
• MDR Report Key: 18951580
• MDR Text Key: 338559578
• Report Number: 1000165971-2024-00250
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014388
• UDI-Public: (01)08031527014388(17)241223(11)240621
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/24/2023
• Device Model Number: PLATINIUM SONR CRT-D 1811
• Device Catalogue Number: TDF034C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• 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