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

Model Number	7735
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right atrial (ra) lead was surgically abandoned due to unknown product performance anomaly.A new lead with different model was implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This supplemental correction report was created to capture the additional information received which indicates that this lead was capped due to physician's discretion as the physician did not like the way the lead looked.This observation no longer meets the definition of malfunction.Amending mdr decision to mdr=no report.
Event or Problem Description
It was reported that this right atrial (ra) lead was surgically abandoned due to unknown product performance anomaly.A new lead with different model was implanted.No additional adverse patient effects were reported.Additional information indicated that this ra lead was capped due to physician's discretion as the physician did not like the way the lead looked.There were no confirmed issues and no 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: 22975383
• Report Number: 2124215-2025-62419
• Device Sequence Number: 18385716
• Product Code: NVN
• UDI-Device Identifier: 00802526523366
• UDI-Public: (01)00802526523366(17)190104
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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
• Report Date (Section B): 10/13/2025

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: 01/04/2019
• Device Model Number: 7735
• Device Catalogue Number: 7735
• Device Lot Number: 630652
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 01/04/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female