MAUDE Adverse Event Report: MICROPORT CRM S.R.L. BOREA; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number BOREA SR 1200

Device Problem Use of Device Problem (1670)

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

Event Date 05/02/2023

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

On (b)(6) 2023, the pacemaker borea sr, sn (b)(6), was interrogated in the office trying to upgrade the software to the version sw 3.12 and by mistake the pop-up of implantation of the device was confirmed.

Manufacturer Narrative

A misuse has been observed on the device by clicking on ok on the pop up message which was to confirm the device implantation.A re-initialization on the field is not possible since a specific tools are needed.No issue on the device was suspected.

Event Description

On (b)(6) 2023, the pacemaker borea sr, sn (b)(6), was interrogated in the office trying to upgrade the software to the version sw 3.12 and by mistake the pop-up of implantation of the device was confirmed.

• Brand Name: BOREA
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 17011090
• MDR Text Key: 316258672
• Report Number: 1000165971-2023-00417
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BOREA SR 1200
• Device Catalogue Number: BOREA SR 1200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic