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

Model Number	PLATINIUM CRT-D 1711
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 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 or Problem 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
• Common Device Name: 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
• Report Number: 1000165971-2024-00066
• Device Sequence Number: 20516146
• Product Code: NIK
• UDI-Device Identifier: 08031527015538
• UDI-Public: (01)08031527015538(17)270118(11)270616
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic