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

Model Number	7731
Medical Device Problem Codes	Fracture (1260); Off-Label Use (1494); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that during a generator change procedure, it was noted that the right ventricular (rv) lead showed a minor fracture in the insulation near the terminal boot, with evidence of old blood present.Despite this finding, rv lead performance remained intact, demonstrating stable measurements.Manipulation of the rv lead did not produce any noise or abnormal signals.Medical adhesive (ma) was applied to repair the insulation, and a sleeve was placed for reinforcement.The device continues to function appropriately and remains in service, and no additional adverse patient effects were noted.
Event or Problem Description
It was reported that during a generator change procedure, it was noted that the right ventricular (rv) lead showed a minor fracture in the insulation near the terminal boot, with evidence of old blood present.Despite this finding, rv lead performance remained intact, demonstrating stable measurements.Manipulation of the rv lead did not produce any noise or abnormal signals.Medical adhesive (ma) was applied to repair the insulation, and a sleeve was placed for reinforcement.The device continues to function appropriately and remains in service, and no adverse patient effects were noted.
Additional Manufacturer Narrative
Correction fields: h6: device codes.This product investigation is still in progress.This report will be updated when product investigation is complete.

• 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 24639529
• Report Number: 2124215-2026-15189
• Device Sequence Number: 16004323
• Product Code: NVN
• UDI-Device Identifier: 00802526523304
• UDI-Public: (01)00802526523304(17)181006
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2026

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: 10/06/2018
• Device Model Number: 7731
• Device Catalogue Number: 7731
• Device Lot Number: 647865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 05/30/2026; 08/03/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 06/23/2026; 08/06/2026
• Date Device Manufactured: 10/06/2016
• 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 Sex: Male