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

Model Number SMARTVIEW REMOTE MONITORING WEBSITE

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/10/2023

Event Type  malfunction  

Event Description

Reportedly, the complaint is regarding remote follow-up transmission report in german.On the (b)(6) 2023, a transmission occurred, with a red alert because of a high right ventricular threshold.- the message under warnings shows wrong values.- the transmission from the (b)(6) 2023 shows the same wrong values when the electrode status is "green" and "ok" although the right ventricular threshold was unsuccessful.- in both transmissions, the translation of the time to rrt is in a wrong language.

Event Description

Reportedly, the complaint is regarding remote fu transmission report.On the (b)(6) a transmission took place, with a red alert because of a high rv threshold.- the message under warnings shows wrong values.(({0:s} v)) - the transmission from the (b)(6) shows the same wrong values under warning.(({0:s} v)) also, the electrodes are "green" and "ok" although the rv threshold was unsuccessful.- in both transmissions, the time to rrt is in the wrong language."tempo hasta rrt" instead of the german equivalent.This appears to be with most pacemaker remote transmissions.

Manufacturer Narrative

Please refer to the attached analysis report.

• 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): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; via crescentino s.n.; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040 ; 146013665
• MDR Report Key: 16930585
• MDR Text Key: 315508230
• Report Number: 1000165971-2023-00392
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• 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: 05/23/2023
• 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