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

Model Number PLATINIUM CRT-D 1711

Device Problem Inappropriate or Unexpected Reset (2959)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

Reportedly, during the interrogation of the subject device, the following warning messages were displayed - [27], [a26] and [a3] indicating the device had been reset 1 time since beginning of life on dec 6, 2023 stating the defibrillation system potentially ineffective.The patient was sent home.The charge time was 13 seconds today with a battery voltage of 2.9v.No other information was available.

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.

Manufacturer Narrative

The conclusions are as follows: - overconsumption has been triggered most probably due to a noisy environment (emis events).- in order to remove this overconsumption, a reset has been performed by the software.- that is the reason why those warnings have been raised.- following the reset, the normal device functioning has been restored.- based on the available data, no issue is suspected on the subject device.For more details, please refer to the attached analysis report.

Event Description

Reportedly, during the interrogation of the subject device, the following warning messages were displayed - [27], [a26] and [a3] indicating the device had been reset 1 time since beginning of life on dec 6, 2023 stating the defibrillation system potentially ineffective.The patient was sent home.The charge time was 13 seconds today with a battery voltage of 2.9v.No other information was available.

• 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: 18535530
• MDR Text Key: 333384212
• Report Number: 1000165971-2024-00066
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527015538
• UDI-Public: (01)08031527015538(17)270118(11)270616
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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 Expiration Date: 01/27/2018
• Device Model Number: PLATINIUM CRT-D 1711
• Device Catalogue Number: TDF033U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2016
• 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