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

Model Number SMARTVIEW CONNECT APP

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

Analysis synthesis: - analysis revealed that the smartview connect application upgrade and the renewal of the certificate most probably occurred at the same time, resulting in a mismatch between the certificate and the private key.As a result, the stored certificate was the wrong one and communication was prevented with the back office, leading to the observed issue.- this case is recorded for trending purposes.

Event Description

Reportedly, two certificates were downloaded by the smartview connect, preventing communication.

• Brand Name: SMARTVIEW CONNECT APP
• Type of Device: 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
• MDR Report Key: 18256230
• MDR Text Key: 329675934
• Report Number: 1000165971-2023-00997
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMARTVIEW CONNECT APP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic