MAUDE Adverse Event Report: MICROPORT CRM S.R.L. CPR4; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number	CPR4 HEAD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon the subject programming head reception, the complaint is confirmed: it presents with cracks in the lower casing on three sides.These cracks were most probably triggered by falls onto a hard surface.The subject programming head is still functioning, but it is likely to sooner or later malfunction since there is possible failure of a surface-mount component.This case is retained for trending purposes.
Event or Problem Description
Reportedly, the subject programming head cpr4 is broken.
Additional Manufacturer Narrative
New mdr for investigation conclusions imdrf code update.Upon the subject programming head reception, the complaint is confirmed: it presents with cracks in the lower casing on three sides.These cracks were most probably triggered by falls onto a hard surface.The subject programming head is still functioning, but it is likely to sooner or later malfunction since there is possible failure of a surface-mount component.This case is retained for trending purposes.
Event or Problem Description
Reportedly, the subject programming head cpr4 is broken.
Event or Problem Description
Reportedly, the subject programming head cpr4 is broken.
Additional Manufacturer Narrative
New fu mdr for investigation conclusions imdrf code update.Upon the subject programming head reception, the complaint is confirmed: it presents with cracks in the lower casing on three sides.These cracks were most probably triggered by falls onto a hard surface.The subject programming head is still functioning, but it is likely to sooner or later malfunction since there is possible failure of a surface-mount component.This case is retained for trending purposes.
Additional Manufacturer Narrative
Udi added to this new mdr follow-up upon the subject programming head reception; the complaint is confirmed: it presents with cracks in the lower casing on three sides.These cracks were most probably triggered by falls onto a hard surface.The subject programming head is still functioning, but it is likely to sooner or later, malfunction since there is possible failure of a surface-mount component.This case is retained for trending proposes.
Event or Problem Description
Reportedly, the subject programming head cpr4 is broken.

• Brand Name: CPR4
• Common Device Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• 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: 23451753
• Report Number: 1000165971-2025-00703
• Device Sequence Number: 9040362
• Product Code: MRM
• 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,Followup,Followup
• Report Date (Section B): 11/04/2025

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: 10/31/2025
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 11/04/2025; 11/04/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/04/2025; 11/04/2025; 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