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

Model Number	7736
Medical Device Problem Codes	High impedance (1291); Insufficient Device Problem Information (3190); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Revision to the initial mdr in block b5 event description h6 device code.This supplemental report was created to capture additional information.
Event or Problem Description
It was reported that this right atrial (ra) lead was surgically abandoned due to product performance anomaly and a new ra lead of the same model was placed.No additional adverse patient effects were reported.Additional information indicates that this lead was capped due to out-of-range impedance measurements and high thresholds.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right atrial (ra) lead was surgically abandoned due to product performance anomaly and a new ra lead of the same model was placed.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: 25034509
• Report Number: 2124215-2026-23218
• Device Sequence Number: 15713310
• Product Code: NVN
• UDI-Device Identifier: 00802526523397
• UDI-Public: (01)00802526523397(17)270117
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 05/15/2026

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 Model Number: 7736
• Device Catalogue Number: 7736
• Device Lot Number: 1111533
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/15/2026
• Date Device Manufactured: 01/17/2025
• 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: 74 YR
• Patient Sex: Male