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

Model Number	7741
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) for review of an episode on the presenting electrogram (egm) for this pacemaker system.Ts reviewed the data and noted there may be atrial loss of capture (loc).Ts also noted the device was programmed oddly and did not believe the episode was slow ventricular tachycardia (vt), rather, loss of av synchrony due to programming.Ts discussed how the device was programmed with the hcp.Information from the field was received and it was believed to be functional loc due to refractory tissue.No adverse patient effects were reported.This right atrial (ra) lead remains in service.
Additional Manufacturer Narrative
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: 50802099
• Report Number: 2124215-2026-49627
• Device Sequence Number: 8652981
• Product Code: NVN
• UDI-Device Identifier: 00802526523458
• UDI-Public: (01)00802526523458(17)200628
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 06/28/2020
• Device Model Number: 7741
• Device Catalogue Number: 7741
• Device Lot Number: 920001
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 06/28/2018
• 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: 76 YR
• Patient Sex: Male