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	12/11/2025
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, the cpr4 head led are out of order.
Additional Manufacturer Narrative
Analysis of the returned subject device confirmed the reported event.When the device is used, on of the blue led and the white led never light up.Opening the device case revealed an issue regarding two resistors, the output potentials at the cathode sides are only a few mv instead of 2.38v.No current can go through the resitor, therefore, the led cannot light up.Traceability shows that the device was manuctured in accordance with all the procedure.Beside the two leds that do not light up, the transmitter works normally.No general malfunction is suspected with the device.This case is retained and utilized for trend purposes.
Event or Problem Description
Reportedly, on 11-december-2025, the cpr4 head led are out of order.

• 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: 23933404
• Report Number: 1000165971-2025-00874
• Device Sequence Number: 9626850
• Product Code: OSR
• UDI-Device Identifier: 08031527019611
• UDI-Public: (01)08031527019611
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/17/2026

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: 12/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 02/17/2026
• 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