MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY? MRI; IMPLANTABLE LEAD

Model Number	7732
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Codes	Adhesion(s) (1695); Valvular Insufficiency/ Regurgitation (4449)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this right ventricular (rv) lead caused severe tricuspid regurgitation due to leaflet entrapment.During lead removal, gentle traction revealed adhesions within the central venous system; these were successfully treated using laser, allowing for complete explantation.A small amount of myocardium was observed on the lead, together with fibrous tissue along the lead body.The patient remained hemodynamically stable throughout the procedure and a transesophageal echocardiography demonstrated moderate tricuspid regurgitation with no evidence of pericardial effusion.A leadless pacemaker was successfully implanted.No additional adverse patient effects were reported.This product was received for analysis.

• Brand Name: INGEVITY? MRI
• 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; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25587825
• Report Number: 2124215-2026-33205
• Device Sequence Number: 5700338
• Product Code: NVN
• UDI-Device Identifier: 00802526523335
• UDI-Public: (01)00802526523335(17)190617
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

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 Expiration Date: 06/17/2019
• Device Model Number: 7732
• Device Catalogue Number: 7732
• Device Lot Number: 660131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male