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

Model Number BOREA DR 1500

Device Problems Inappropriate or Unexpected Reset (2959); Insufficient Information (3190)

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

Event Date 08/22/2023

Event Type  malfunction  

Event Description

Reportedly, when interrogated for the first time, the borea dr pacemaker was in vvi mode.And there was a notification saying that the pacemaker has been reset 14 times.

Manufacturer Narrative

The analysis of the provided files led to the following observations: - 14 resets occurred on (b)(6) 2023 - the device reset because of crosstalk that had occurred with another device being in a too close vicinity at the time of interrogation (leading to data inconsistencies).No issue is suspected on the device.

Event Description

Reportedly, when interrogated for the first time, the borea dr pacemaker was in vvi mode.And there was a notification saying that the pacemaker has been reset 14 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 ; 146013665
• MDR Report Key: 17772651
• MDR Text Key: 323706409
• Report Number: 1000165971-2023-00740
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BOREA DR 1500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 10/20/2023
• 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