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

Model Number	CPR4 HEAD
Medical Device Problem Code	Intermittent Continuity (1121)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportedly, during follow-ups, the communication between the programmer and the implantable device was interrupted several times despite a good positioning of the programming head on the implantable device.The cable is bent at the level of the usb connector and this may trigger a bad electrical contact.
Additional Manufacturer Narrative
Upon reception, the reported issue is confirmed: the 4 white leds light up for a maximum of 2 seconds before turning off; no blue leds on when in front a pacemaker.The investigation of the subject crp4 programming head showed that: ¿ the usb/pcb cable is out of service; ¿ the electronics of the subject cpr4 head are undamaged (ok).After testing the continuity of each colored wire in the cable, between the usb side and the connector side connected to the pcb, it was found that the connection of the blue wire ("shield") is broken.The traceability of the subject crp4 head is correct, all the electrical tests of the cpr4 head were correct at the first pass.It was working well when delivered to the field.The most probable hypothesis is that the cable would be damaged in the field.This case is retained for trending purposes.
Additional Manufacturer Narrative
Udi added to this follow-up mdr upon reception, the reported issue is confirmed: the 4 white leds light up for a maximum of 2 seconds before turning off; no blue leds on when in front a pacemaker.The investigation of the subject crp4 programming head showed that: the usb/pcb cable is out of service; the electronics of the subject cpr4 head are undamaged (ok).After testing the continuity of each colored wire in the cable, between the usb side and the connector side connected to the pcb, it was found that the connection of the blue wire ("shield") is broken.The traceability of the subject crp4 head is correct, all the electrical tests of the cpr4 head were correct at the first pass.It was working well when delivered to the field.The most probable hypothesis is that the cable would be damaged in the field.This case is retained for trending purposes.
Event or Problem Description
Reportedly, during follow-ups, the communication between the programmer and the implantable device was interrupted several times despite a good positioning of the programming head on the implantable device.The cable is bent at the level of the usb connector and this may trigger a bad electrical contact.

• 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: 23484253
• Report Number: 1000165971-2025-00709
• Device Sequence Number: 10559028
• Product Code: OSR
• UDI-Device Identifier: 08031527019611
• UDI-Public: (01)08031527019611
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: 10/15/2025
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/06/2025
• 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