MAUDE Adverse Event Report: MICROPORT CRM S.R.L. CPR3; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

Model Number	CPR3 HEAD
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device and files investigation is still ongoing, results will be available on the next report.
Event or Problem Description
Reportedly, on (b)(6) 2026, interrogation issue occurred.On/off tablet button is damaged.
Event or Problem Description
Reportedly, on 28-january-2026, interrogation issue occurred.On/off tablet button is damaged.
Additional Manufacturer Narrative
Analysis of the returned devices permit to reproduce the reported event.Upon reception, the programmer, telemetry head and dongle were tested together and interrogation could not be performed.It was observed that the dongle was damaged (cable twisted).The programmer and telemetry head were therefore tested with another dongle and they worked correctly.Considering these findings, the damaged dongle caused communication issue.No malfunction is suspected on the programmer and telemetry head.This case is retained and utilized for trend purposes.

• Brand Name: CPR3
• 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: 24452447
• Report Number: 1000165971-2026-00123
• Device Sequence Number: 21158282
• Product Code: OSR
• UDI-Device Identifier: 08031527019611
• UDI-Public: (01)08031527019611
• Combination Product (Y/N): N
• PMA/510(K) Number: P980049
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: CPR3 HEAD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown