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

Model Number	CPR4 HEAD
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the subject device has not been returned yet, no investigation could be performed.Results will be provided on the next report.
Event or Problem Description
Reportedly, on (b)(6) 2025, interrogation of a device before mri is impossible.
Additional Manufacturer Narrative
Analysis of the returned subject devices confirmed the reported event.The communication error is caused by a hardware failure related to cpr4 head.The usb cable of the programming head is faulty and cause communication failure.Multiple cracks are visible on the programming head.Beside, the smarttouch tablet was tested and worked normally with another programming head.The most probable hypothesis is that an unintentionel user error caused the hardware failure on usb cable.This case is retained and utilized for trend purposes.
Event or Problem Description
Reportedly, on (b)(6) 2025, interrogation of a device before mri is impossible.

• 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: 23825436
• Report Number: 1000165971-2025-00817
• Device Sequence Number: 5068073
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/09/2026
• 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