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

Model Number	7842
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Pacing Problem (1439)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited noisy signals due to unexpected programming.Additionally, a red alert was found for high out of range pace impedance measurements.Technical services (ts) was consulted and found the system to be operating in unipolar rather than bipolar with no previous history of a lead safety switch.Ts believed a bigger lead anomaly was present but have no confirmation at this time.Ts noted that pacing inhibition greater than 2 seconds had occurred at times.No additional adverse patient effects were reported.This rv lead remains in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.If pertinent information is provided in the future, a supplemental report will be submitted.

• 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: 50932547
• Report Number: 2124215-2026-51659
• Device Sequence Number: 9525908
• Product Code: NVN
• UDI-Device Identifier: 00802526604522
• UDI-Public: (01)00802526604522(17)230410
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare 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 Expiration Date: 04/10/2023
• Device Model Number: 7842
• Device Catalogue Number: 7842
• Device Lot Number: 1041713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 04/10/2021
• 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: 82 YR
• Patient Sex: Female