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

Model Number	7840
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the health care professional (hcp) requested a non-conditional magnetic resonance imaging (mri) scan on device with high out of range pacing impedance measurements on this right atrial (ra) lead.Technical services (ts) was consulted for further review.Upon review, the stored electrogram (egm) showed a lead safety switch (lss) from bipolar to unipolar configuration due to high out of range pacing impedance measurements.Further review of stored atrial tachy response (atr) events showed ra lead also exhibited myopotential oversensing noise.It was suspected cause to be due to lead fracture.No adverse patient effects were reported.At this time, this ra lead remains in service.
Additional Manufacturer Narrative
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: 50804608
• Report Number: 2124215-2026-49695
• Device Sequence Number: 10549007
• Product Code: NVN
• UDI-Device Identifier: 00802526604430
• UDI-Public: (01)00802526604430(17)271111
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare 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 Model Number: 7840
• Device Catalogue Number: 7840
• Device Lot Number: 1160504
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 11/11/2025
• 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 Sex: Female