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

Model Number SMARTVIEW REMOTE MONITORING WEBSITE

Device Problems Computer Software Problem (1112); Data Problem (3196)

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

Event Date 07/27/2023

Event Type  malfunction  

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, rms follow-up done on (b)(6) 2023 for an astral patient, pdf and idf received for anonymization and help to fill out the study case report form (crf).Several issues were observed by the fcs on the idf file: - there is no name in the file (before trying to anonymise it), - in the manager the patient name is replaced by several different characters (letters, numbers, special characters).- in the file, the patient name is replaced by ???.- in the patient screen all information is missing (yellow boxes).- in the pdf file : impedance > 0 ohms (very high impedance on the lv lead 4102 ohms because it is an axone lead), - in the pdf file: alert not available written at several places (for all leads and summary implant information).

Event Description

Reportedly, an empty remote report was transmitted on (b)(6) 2023 for the platinium sonr crt-d 1811 s/n (b)(6).The associated file can still be read on a programmer.

Manufacturer Narrative

Please refer to the attached analysis report.Analysis synthesis: - analysis of available expertise data confirmed the reported behavior, as the remote transmission was not generated.- in-depth analysis revealed that the observed issue resulted from a rare software malfunction at the level of the back office, which failed to free ports in the server and therefore could not complete the generation process.As a result, the remote transmission could not be generated correctly, leading to the observed issue.- this case is recorded for trending purposes.

• Brand Name: SMARTVIEW REMOTE MONITORING WEBSITE
• 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: 17609969
• MDR Text Key: 321816088
• Report Number: 1000165971-2023-00642
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMARTVIEW REMOTE MONITORING WEBSITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2023
• 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