SMARTVIEW
Report
- Report Number
- 1000165971-2023-00337
- Event Type
- Malfunction
- Date Received
- April 18, 2023
- Date of Event
- March 21, 2023
- Report Date
- June 20, 2023
- Manufacturer
- SORIN GROUP ITALIA S.R.L. - CRM FACILITY
- Product Code
- OSR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
PRELIMINARY ANALYSIS REVEALED THAT THE OBSERVED ISSUE RESULTED FROM A SERVER ISSUE.
REPORTEDLY, THE REMOTE REPORT ASSOCIATED TO ALIZEA PACEMAKER S/N (B)(4) COULD NOT BE READ AS THE MESSAGE 'SERVER ERROR IN '/' APPLICATION' WAS DISPLAYED, WITH A CRITICAL ALERT FROM 10 FEBRUARY 2023. THE PATIENT REPORTEDLY HAD A STROKE AND THE EPISODES IN THE DEVICE MEMORY WILL BE INVESTIGATED.
REPORTEDLY, THE REMOTE REPORT ASSOCIATED TO ALIZEA PACEMAKER S/N (B)(6) COULD NOT BE READ AS THE MESSAGE 'SERVER ERROR IN '/' APPLICATION' WAS DISPLAYED, WITH A CRITICAL ALERT FROM (B)(6) 2023. THE PATIENT REPORTEDLY HAD A STROKE AND THE EPISODES IN THE DEVICE MEMORY WILL BE INVESTIGATED. PRELIMINARY ANALYSIS REVEALED THAT THE OBSERVED ISSUE RESULTED FROM A SERVER ISSUE.
REPORTEDLY, THE REMOTE REPORT ASSOCIATED TO ALIZEA PACEMAKER S/N: (B)(6) COULD NOT BE READ AS THE MESSAGE 'SERVER ERROR IN '/' APPLICATION' WAS DISPLAYED, WITH A CRITICAL ALERT FROM ON (B)(6) 2023. THE PATIENT REPORTEDLY HAD A STROKE AND THE EPISODES IN THE DEVICE MEMORY WILL BE INVESTIGATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1044815 | SMARTVIEW | PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS | OSR | SORIN GROUP ITALIA S.R.L. - CRM FACILITY | SMARTVIEW REMOTE MONITORING WEBSITE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |