MAUDE Adverse Event Report: MicroPort CRM S.r.l. CPR4; Pacemaker/Icd/Crt Non-Implanted Components

Model Number	CPR4 HEAD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction

• 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: anne rousseau-plasse ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040 ; +33(146)013082
• MDR Report Key: 50537848
• Report Number: 1000165971-2026-04100
• Device Sequence Number: 5951953
• Product Code: OSR
• UDI-Device Identifier: 08031527019611
• UDI-Public: (01)08031527019611
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CPR4 HEAD
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown