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	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the returned subject devices confirmed the reported event.The issue seems to be related to the programmer as the error message "guiapp invalid argument encountered" is displayed when an inductive communication is tried.The cpr4 head works normally with another programmer.Review of the files is still ongoing, results are not available yet.
Event or Problem Description
Reportedly, on (b)(6) 2025, it was impossible to interrogate patient device.An error message is display.Rebooting the tablet several times did not resolve the issue.Replacing the programmer and programming head resolved the issue.
Additional Manufacturer Narrative
Analysis of the returned subject programmer confirmed the reported event.When an interrogation is tried, an error message is displayed and therefore interrogation is not possible.Analysis of the returned subject telemetry head did not reveal any malfunction as it is working normally, it is not suspected to be related to the reported event.Review of the extracted files confirmed the reported event as the registry file of the bradywireless programmer is corrupted.This type of corruption is caused by several brutal shutdown.This case is retained and utilized for trend purposes.
Event or Problem Description
Reportedly, on (b)(6) 2025, it was impossible to interrogate patient device.An error message is display.Rebooting the tablet several times did not resolve the issue.Replacing the programmer and programming head resolved the issue.

• 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: 23307958
• Report Number: 1000165971-2025-00657
• Device Sequence Number: 5135096
• Product Code: OSR
• UDI-Device Identifier: 08031527019611
• UDI-Public: (01)08031527019611
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• 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,Followup
• Report Date (Section B): 11/24/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2025
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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