MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY? MRI; Implantable Lead

Model Number	7731
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Pacing Problem (1439)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
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 exhibited noise that prevented atrial pacing.Technical services (ts) reviewed the data and discussed this was normal device function.Upon review, ts also noted pacing inhibition for longer than two seconds.Ts also mentioned the rv lead was set to unipolar pacing and sensing after a sudden increase to an out-of-range pacing impedance measurement.It was also noted this rv lead exhibited loss of capture (loc) and the lead would be revised.No additional adverse patient effects were reported.This rv lead remains in service.

• 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; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25638397
• Report Number: 2124215-2026-34186
• Device Sequence Number: 21291347
• Product Code: NVN
• UDI-Device Identifier: 00802526523304
• UDI-Public: (01)00802526523304(17)250112
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/12/2025
• Device Model Number: 7731
• Device Catalogue Number: 7731
• Device Lot Number: 1074577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 01/12/2023
• 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
• Patient Age: 84 YR
• Patient Sex: Female