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

Model Number	7742
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited a potential fracture and was programmed for unipolar pacing.In addition, the patient was scheduled to undergo hyperbaric oxygen therapy (hbot).Technical services (ts) advised that the device has been tested for hbot exposure up to 5.0 atmospheres absolute (ata) and that no restrictions apply regarding the lead anomaly or unipolar pacing.To date, this rv lead remains in service.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; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50943050
• Report Number: 2124215-2026-51913
• Device Sequence Number: 13374762
• Product Code: NVN
• UDI-Device Identifier: 00802526523489
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/15/2020
• Device Model Number: 7742
• Device Catalogue Number: 7742
• Device Lot Number: 792236
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 01/15/2018
• 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: 70 YR
• Patient Sex: Male