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

Model Number	7841
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right atrial (ra) lead exhibited loss of capture (loc) on a presenting electrogram (egm) and then in clinic when evaluating.The health care professional (hcp) will obtain x ray imaging and decide on next steps.Additional information is being requested from the field.This ra lead remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this right atrial (ra) lead exhibited loss of capture (loc) on a presenting electrogram (egm) and then in clinic when evaluating.The health care professional (hcp) will obtain x ray imaging and decide on next steps.Additional information is being requested from the field.This ra lead remains in service.No additional adverse patient effects were reported.The lead was not returned for analysis as it remains in service; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.Additional information was received that the field representative had no further information from the hcp.
Additional Manufacturer Narrative
The lead was not returned for analysis as it remains in service; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.
Additional Manufacturer Narrative
The lead was not returned for analysis as it remains in service; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.

• Brand Name: INGEVITY?+
• 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: 50932065
• Report Number: 2124215-2026-51645
• Device Sequence Number: 9508986
• Product Code: NVN
• UDI-Device Identifier: 00802526604577
• UDI-Public: (01)00802526604577(17)280610
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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 Model Number: 7841
• Device Catalogue Number: 7841
• Device Lot Number: 1728990
• 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: 09/16/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 06/11/2026
• 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
• Patient Age: 47 YR
• Patient Sex: Unknown