MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY?+; Drug Eluting Permanent Right Ventricular or Atrial Pacemaker Electrodes

Model Number	7840
Medical Device Problem Codes	Failure to Capture (1081); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Health Effect - Clinical Codes	Bradycardia (1751); Fatigue (1849)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right atrial (ra) lead exhibited loss of capture (loc) with elevated capture thresholds.Upon review, the lead appeared to be dislodged slightly.A revision procedure was performed and the ra lead was repositioned.The lead was again not clearly capturing and the patient reportedly felt fatigued.The patient was recommended to follow up with their clinic for thorough lead testing.This ra lead remains in service.No additional adverse patient effects were reported.

• Brand Name: INGEVITY?+
• Common Device Name: Drug Eluting Permanent Right Ventricular or Atrial Pacemaker Electrodes
• 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: 50805338
• Report Number: 2124215-2026-49714
• Device Sequence Number: 13405742
• Product Code: NVN
• UDI-Device Identifier: 00802526604430
• UDI-Public: (01)00802526604430(17)280429
• 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: Health Professional
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 7840
• Device Catalogue Number: 7840
• Device Lot Number: 1170532
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 04/30/2026
• 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 Sex: Female