MAUDE Adverse Event Report: MICROPORT CRM S.R.L. CPR4; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

Model Number	CPR4 HEAD
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the provided files confirmed that communication error occurred on (b)(6) 2025 during an alizea dr session.After this error the ble command failed as ble communication cannot be achieved with the implant.Therefore, the user tried to reinterrogate, without success, and removed the battery.This type of ble loss is caused by a windows error, preventing the ble communication.The telemetry head is not suspected to be defective.A workaround if this type of event reoccurred is to switch the communication to inductive mode, or to quit the session properly before trying to reinterrogate.This case is retained and utilized for trend purposes.
Event or Problem Description
Reportedly, on (b)(6) 2025, the bluetooth is lost during implantation of alizea devices.

• Brand Name: CPR4
• Common Device Name: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• 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: 23847447
• Report Number: 1000165971-2025-00837
• Device Sequence Number: 9445387
• Product Code: OSR
• UDI-Device Identifier: 08031527019611
• UDI-Public: (01)08031527019611
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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 Model Number: CPR4 HEAD
• 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: 12/18/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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