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

Model Number	7735
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this right atrial (ra) lead exhibited a fracture.As a result, high out of range pacing impedance measurements were observed.Technical services (ts) recommended reprogramming options to avoid the ra alerts.No adverse patient effects were reported.This ra lead remains in service.
Additional Manufacturer Narrative
This report is being submitted to update section b1, b5, h1, and h6 codes.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this right atrial (ra) lead exhibited a fracture.As a result, high out of range pacing impedance measurements were observed.Technical services (ts) recommended reprogramming options to avoid the ra alerts.No adverse patient effects were reported.This ra lead remains in service.Additional information indicated that this ra lead was surgically abandoned and successfully replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The device was not returned for analysis as it was surgically abandoned; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.This report is being submitted to update section b1, b5, h1, and h6 codes.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this right atrial (ra) lead exhibited a fracture.As a result, high out of range pacing impedance measurements were observed.Technical services (ts) recommended reprogramming options to avoid the ra alerts.No adverse patient effects were reported.This ra lead remains in service.Additional information indicated that this ra lead was surgically abandoned and successfully replaced.No additional adverse patient effects were reported.

• 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: 23791468
• Report Number: 2124215-2025-90644
• Device Sequence Number: 10470587
• Product Code: NVN
• UDI-Device Identifier: 00802526523366
• UDI-Public: (01)00802526523366(17)190824
• 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: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/24/2019
• Device Model Number: 7735
• Device Catalogue Number: 7735
• Device Lot Number: 633167
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 04/08/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 12/23/2025; 04/14/2026
• Date Device Manufactured: 08/24/2017
• 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
• Patient Age: 75 YR
• Patient Sex: Male