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 Device Displays Incorrect Message (2591)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

Reportedly, the date of the last transmission displayed on smartview connect was (b)(6) 1970.

Manufacturer Narrative

Additional information about the manufacturer name and address in section d3.Correction of the initial reporter function changed from non-healthcare to others and company representative in section e3.Analysis summary: upon reception, the returned home monitor was tested, and the reported issue was confirmed: the status light of the subject home monitor was constantly lighting in orange.- in-depth analysis of the returned unit revealed that the confirmed issue is due to a short circuit between the printed circuit board (pcb) and the ground.- the root cause of this short circuit is most probably associated to an issue at the manufacturing level.

Event Description

Reportedly, the date of the last transmission displayed on smartview connect was (b)(6) 1970.

• Brand Name: SMARTVIEW CONNECT APP
• Type of Device: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• 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 ; 146013665
• MDR Report Key: 18696586
• MDR Text Key: 336432821
• Report Number: 1000165971-2024-00139
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SMARTVIEW CONNECT APP
• Device Catalogue Number: SMARTVIEW CONNECT APP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2024
• 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
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic