MAUDE Adverse Event Report: MICROPORT CRM S.R.L. VEGA; DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR RIGHT ATRIAL PACEMAKER ELECTRODES

Model Number	VEGA R52
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericarditis (4448)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient developed pericarditis secondary to a late lead perforation.The lead was positioned in the rv and was connected to an impulse dynamics optimizer smart mini generator.Lead measurements at implant were 0.9v@0.5ms, 11mv, & 870ohms.The patient also has a boston scientific s-icd implanted.
Additional Manufacturer Narrative
The manufacturing process for the lead was re-investigated.And all production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process which might be related to the reported issue.A reintervention was performed to explant the subject lead the first of july 2025.As the suspected lead was not returned and based on available information, it should be noted that cardiac perforation may be attributable to factors such as patient physiology or physician preferred implant site, which are independent of the lead characteristics.Furthermore, cardiac perforation is a well-known potential complication associated to such implantable devices, discussed in published literature.The results of this investigation are retained and utilized for trending purposes.
Event or Problem Description
Patient developed pericarditis secondary to a late lead perforation.The lead was positioned in the rv and was connected to an impulse dynamics optimizer smart mini generator.Lead measurements at implant were 0.9v@0.5ms, 11mv, & 870ohms.The patient also has a boston scientific s-icd implanted.

• Brand Name: VEGA
• Common Device Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR RIGHT ATRIAL PACEMAKER ELECTRODES
• 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: 24266185
• Report Number: 1000165971-2026-00053
• Device Sequence Number: 21497306
• Product Code: NVN
• UDI-Device Identifier: 08031527019796
• UDI-Public: (01)08031527019796(11)230708(17)260708
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P130010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2026
• Device Model Number: VEGA R52
• Device Catalogue Number: TLD041U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown