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

Model Number	7735
Medical Device Problem Codes	Failure to Capture (1081); Fracture (1260); High impedance (1291); Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fatigue (1849); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right atrial (ra) lead was explanted due to unknown product performance anomaly.A new lead with the same model was implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right atrial (ra) lead was explanted due to unknown product performance anomaly.A new lead with the same model was implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Revision to fields h1 type of reportable event and e1 initial reporter email.This supplemental report has been created to capture additional information and information correction.
Event or Problem Description
It was reported that this right atrial (ra) lead was explanted due to unknown product performance anomaly.A new lead with the same model was implanted.No additional adverse patient effects were reported.Additional information indicated that this ra lead was explanted due to lead fracture with impedance greater than 3000 ohms and was no longer able to capture.There were no adverse patient effects.Also, this lead will not be returned.
Additional Manufacturer Narrative
Revision to fields h1 type of reportable event and e1 initial reporter email.This supplemental report has been created to capture additional information and information correction.
Additional Manufacturer Narrative
Revision to fields h1 type of reportable event and e1 initial reporter email.This supplemental report has been created to capture additional information and information correction.Revision to fields b5 describe event or problem, f10 patient codes and h6 patient codes.This supplemental report has been created to capture additional information and information correction.
Event or Problem Description
It was reported that this right atrial (ra) lead was explanted due to unknown product performance anomaly.A new lead with the same model was implanted.No additional adverse patient effects were reported.Additional information indicated that this ra lead was explanted due to lead fracture with impedance greater than 3000 ohms and was no longer able to capture.There were no adverse patient effects outside of slightly more tired per the clinic.Also, this lead will not be returned.

• 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: 23410041
• Report Number: 2124215-2025-77549
• Device Sequence Number: 9131800
• Product Code: NVN
• UDI-Device Identifier: 00802526523366
• UDI-Public: (01)00802526523366(17)240523
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 01/26/2026

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: 05/23/2024
• Device Model Number: 7735
• Device Catalogue Number: 7735
• Device Lot Number: 1007833
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 11/21/2025; 01/26/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/12/2025; 11/30/2025; 01/26/2026
• Date Device Manufactured: 05/23/2022
• 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: 65 YR
• Patient Sex: Male