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 Delayed Charge Time (2586)

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

Event Date 12/21/2023

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 user realised that charge time was long (16s).According to the ifu rrt should be reached when the charge time is 16s, however it is not rrt and the remaining longevity is 3 to 5 years and the voltage is 2,91v.It seemes that the information on the ifu is not in accordance to the observed charge time.

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.Additional information received this afternoon and added in the final response: "on (b)(6) 2024, the charge time is the one performed on (b)(6) 2023: 16 seconds.The battery voltage is still 2,91 v, same the battery voltage on (b)(6) 2023 and the time to rrt is still 3 to 5 years" the review of provided data confirmed the reported description: the charge time is 16 seconds, however the device hasn¿t reached the rrt, the remaining longevity is 3 to 5 years and the voltage is 2,91v.The charge time measurement during the manufacturing of the device is normal and well centred in the acceptance range.The detailed analysis of the battery curve shows normal curve and no sign of irregular behaviour since the beginning of life of the subject device.The current consumption is normal, considering that rv and lv are paced at 100%: the charge times are at the higher limit of the acceptable range.Provided data do not provide any evidence of anomaly in the subject device nor in the system.Since the subject device is connected to the remote monitoring system, the alert for rrt will be automatically sent to the center and regular remote follow-ups can be put in place if not already done in order to follow-up on the charge time and the battery voltage.No general malfunction is suspected on the device.This case is retained and utilized for trend purposes.

Event Description

Reportedly, the user realised that charge time was long (16s).According to the ifu rrt should be reached when the charge time is 16s, however it is not rrt and the remaining longevity is 3 to 5 years and the voltage is 2,91v.It seemes that the information on the ifu is not in accordance to the observed charge time.

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 review of provided data confirmed the reported description: the charge time is 16 seconds, however the device hasn¿t reached the rrt, the remaining longevity is 3 to 5 years and the voltage is 2,91v.The charge time measurement during the manufacturing of the device is normal and well centred in the acceptance range.The detailed analysis of the battery curve shows normal curve and no sign of irregular behaviour since the beginning of life of the subject device.The current consumption is normal, considering that rv and lv are paced at 100%: the charge times are at the higher limit of the acceptable range.Provided data do not provide any evidence of anomaly in the subject device nor in the system.Since the subject device is connected to the remote monitoring system, the alert for rrt will be automatically sent to the center and regular remote follow-ups can be put in place if not already done in order to follow-up on the charge time and the battery voltage.No general malfunction is suspected on the device.This case is retained and utilized for trend purposes.

Event Description

Reportedly, the user realised that charge time was long (16s).According to the ifu rrt should be reached when the charge time is 16s, however it is not rrt and the remaining longevity is 3 to 5 years and the voltage is 2,91v.It seemes that the information on the ifu is not in accordance to the observed charge time.

• 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: 18484359
• MDR Text Key: 332628331
• Report Number: 1000165971-2024-00043
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014388
• UDI-Public: (01)08031527014388(17)260920(11)260219
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2020
• Device Model Number: PLATINIUM SONR CRT-D 1811
• Device Catalogue Number: TDF034C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• 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