MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY?+; Implantable lead

Model Number	7841
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this right atrial (ra) lead experienced a pericardial effusion.Earlier this year, approximately 1000 cubic centimeters (cc) of fluid were drained from the pericardial space.Three days later, an additional 350 cc of fluid was removed.The patient was subsequently monitored with periodic echocardiograms.No recurrence of fluid accumulation has been observed to date.At this time, this ra lead remains in service.No additional adverse patient effects were reported.

• Brand Name: INGEVITY?+
• Common Device Name: Implantable lead
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50935443
• Report Number: 2124215-2026-51734
• Device Sequence Number: 21223420
• Product Code: NVN
• UDI-Device Identifier: 00802526604577
• UDI-Public: (01)00802526604577(17)270904
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 7841
• Device Catalogue Number: 7841
• Device Lot Number: 1674102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 09/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female