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

Model Number	7741
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Fracture (1260); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited possible loss of capture (loc).Technical services (ts) was consulted and confirmed evidence of loc, as well as pacing inhibition greater than two seconds, which was associated with a syncopal episode experienced by the patient.The rv lead was suspected to be fractured.Subsequently, the patient underwent a replacement procedure; however, due to venous occlusion, the physician elected to cap both the rv and right atrial (ra) leads and explant the existing device.A new system was then implanted on the left side.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• 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: 50658538
• Report Number: 2124215-2026-47705
• Device Sequence Number: 10235401
• Product Code: NVN
• UDI-Device Identifier: 00802526523458
• UDI-Public: (01)00802526523458(17)190605
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2026

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: 06/05/2019
• Device Model Number: 7741
• Device Catalogue Number: 7741
• Device Lot Number: 782025
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/07/2026
• Date Device Manufactured: 06/05/2017
• 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: 89 YR
• Patient Sex: Female