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

Model Number BOREA SR 1200

Device Problem Pacemaker Found in Back-Up Mode (1440)

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

Event Date 11/22/2022

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.Preliminary analysis revealed that the reported event resulted from cross-talk disturbances.

Event Description

Reportedly, a borea pacemaker was interrogated with a smarttouch tablet in order to perform the 3.12 software upgrade, but a pop-up message appeared, indicating that the device was in stand-by mode and needed a reset.The reset was therefore performed, but then the upgrade could not be performed.In addition, it was indicated that the pacemaker was already reset 4 times.Preliminary analysis revealed that the reported event resulted from cross-talk disturbances.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, a borea pacemaker was interrogated with a smarttouch tablet in order to perform the 3.12 software upgrade, but a pop-up message appeared, indicating that the device was in stand-by mode and needed a reset.The reset was therefore performed, but then the upgrade could not be performed.In addition, it was indicated that the pacemaker was already reset 4 times.

• 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: 16003824
• MDR Text Key: 305846292
• Report Number: 1000165971-2022-00595
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2023
• 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