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

Model Number	7732
Medical Device Problem Codes	Failure to Capture (1081); Pacing Problem (1439); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a routine follow up; this right ventricular (rv) lead was suspected to be dislodged.It was also noted this rv lead exhibited loss of capture (loc) and pacing inhibition.The pacing inhibition lasted one second.The patient was sent for an x-ray, which confirmed the lead was dislodged.A lead revision procedure was performed, and a new rv lead was implanted to resolve the pacing inhibition.This rv lead was surgically abandoned.No additional adverse patient effects were reported.
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 routine follow up, this right ventricular (rv) lead was suspected to be dislodged.It was also noted this rv lead exhibited loss of capture (loc) and pacing inhibition.The pacing inhibition lasted one second.The patient was sent for an x-ray, which confirmed the lead was dislodged.A lead revision procedure was performed, and a new rv lead was implanted to resolve the pacing inhibition.This rv lead was surgically abandoned.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This report is being submitted to correct the information in section h6.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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25446924
• Report Number: 2124215-2026-30761
• Device Sequence Number: 21215756
• Product Code: NVN
• UDI-Device Identifier: 00802526523335
• UDI-Public: (01)00802526523335(17)280114
• Combination Product (Y/N): Y
• Initial Reporter State: PR
• Initial Reporter Country: PR
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/11/2026

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: 7732
• Device Catalogue Number: 7732
• Device Lot Number: 1094197
• 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: 05/12/2026
• Supplement Date Received by Manufacturer: 06/09/2026; 07/13/2026; 08/24/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 06/09/2026; 07/14/2026; 09/11/2026
• Date Device Manufactured: 01/14/2026
• 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: 89 YR
• Patient Sex: Male