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

Model Number SMARTVIEW REMOTE MONITORING WEBSITE

Device Problems Computer Software Problem (1112); Patient Data Problem (3197)

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

Event Date 12/14/2023

Event Type  malfunction  

Event Description

Patient included in astral study.Hospital has downloaded idf file from smartview website in order to report the visit according to microport recommendations.This idf when it's open in the programmer shows the patient data in yellow (erased).

• Brand Name: SMARTVIEW BOA
• 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: 18503996
• MDR Text Key: 333093859
• Report Number: 1000165971-2024-00050
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 02/06/2024
• 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