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

Model Number	7731
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Nonstandard Device (1420); Impedance Problem (2950); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead was explanted due to unknown product performance anomaly.A new rv lead with a different model was successfully implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right ventricular (rv) lead was explanted due to unknown product performance anomaly.A new rv lead with a different model was successfully implanted.The lead was returned for analysis.No additional adverse patient effects were reported.Additional information received indicates that this rv lead exhibited abnormal impedance, noisy signals, and loss of capture (loc).This rv lead was received for analysis.
Additional Manufacturer Narrative
Additional information added to b5.F10 and h6 updated.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 this right ventricular (rv) lead was explanted due to unknown product performance anomaly.A new rv lead with a different model was successfully implanted.The lead was returned for analysis.No additional adverse patient effects were reported.Additional information received indicates that this rv lead exhibited abnormal impedance, noisy signals, and loss of capture (loc).
Additional Manufacturer Narrative
This product was explanted but was not returned.As such, physical analysis has not been conducted in our laboratory.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Based on a thorough review of the reported complaint, the conclusion code cause traced to device design was assigned, because the reported observation of fractured lead conductors consistent with clavicle crush.The damage occurred during normal use.

• 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: 24689559
• Report Number: 2124215-2026-16348
• Device Sequence Number: 9976843
• Product Code: NVN
• UDI-Device Identifier: 00802526523304
• UDI-Public: (01)00802526523304(17)210410
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2026

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: 04/10/2021
• Device Model Number: 7731
• Device Catalogue Number: 7731
• Device Lot Number: 1003945
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/08/2026
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/09/2026; 09/24/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/21/2026; 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2019
• 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: 70 YR
• Patient Sex: Female