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

Model Number	CPR4 HEAD
Medical Device Problem Code	Telemetry Discrepancy (1629)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
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 8-january-2026, the cpr4 head is unusable to interrogate.
Additional Manufacturer Narrative
Analysis of the returned subject device confirmed the reported event.When the telemetry head is used for interrogate, a communication error occurred.Investigation of the internal components did not reveal any signs of oxydation or damage.After reassembling the telemetry head, it finally works normally.The most probable hypothesis is that a momentary micro-dislodgement of an internal components caused the reported event.This type of micro-dislodgement can be caused by a fall on the ground (confirmed by the presence of cracks on the white case of the telemetry head).No general malfunction is suspected with the subject device.This case is retained and utilized for trend purposes.
Event or Problem Description
Reportedly, on (b)(6) 2026, the cpr4 head is unusable to interrogate.

• 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: 24268616
• Report Number: 1000165971-2026-00054
• Device Sequence Number: 10726045
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: CPR4 HEAD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown