MAUDE Adverse Event Report: MICROPORT CRM S.R.L. VEGA; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number VEGA R52

Device Problem Device Sensing Problem (2917)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2021

Event Type  malfunction  

Event Description

According to the patient files provided, atrial sensing issues were observed (atrial spikes detected on the ventricular channel and some ventricular extra systoles are detected by the atrial lead).

Manufacturer Narrative

The patient files analysis confirmed the issue with the atrial lead.The production record review revealed that the vega lead was released following all applicable procedures.Additional investigations are currently ongoing.A new follow-up will be performed as soon as the results are available.

Event Description

According to the patient files provided, atrial sensing issues were observed (atrial spikes detected on the ventricular channel and some ventricular extra systoles are detected by the atrial lead).

Event Description

According to the patient files provided, atrial sensing issues were observed (atrial spikes detected on the ventricular channel and some ventricular extra systoles are detected by the atrial lead).

Manufacturer Narrative

Summary of the investigation: devices history reports (dhr) analysis show that the lead related to this report meets all the requirements of the specification at inspection.The analysis did not present any product rejections during the manufacturing process, nor deviations that could result in the reported incident.Almost all the episodes recorded in the device memory showed abnormal a spikes which lead to a ventricular contraction.If the lead still implanted, a careful monitoring of the atrial lead integrity should be performed to ensure the adequate sensing and pacing functionality (refer to the recommendations below).This case is retained and utilized for trending purposes.For more details, please refer to the enclosed report analysis.

• Brand Name: VEGA
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• 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: 18985062
• MDR Text Key: 338659844
• Report Number: 1000165971-2024-00278
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: DR
• PMA/PMN Number: P130010
• 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,Followup
• Report Date: 05/31/2024

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 Expiration Date: 10/14/2022
• Device Model Number: VEGA R52
• Device Catalogue Number: TLD041C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/15/2024; Not provided
• Supplement Dates FDA Received: 05/15/2024; 05/31/2024
• 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