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

Model Number	SMARTVIEW CONNECT APP
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction

• Brand Name: Smartview Connect App
• 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: 50339041
• Report Number: 1000165971-2026-04094
• Device Sequence Number: 5483469
• Product Code: OSR
• UDI-Device Identifier: 08031527019932
• UDI-Public: (01)08031527019932(10)202410
• 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
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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: Lay User/Patient
• Device Model Number: SMARTVIEW CONNECT APP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown