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

Model Number	7841
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right atrial (ra) lead was a case of an attempted implant due to terminal pin anomaly on the ra lead.As the ra lead was implanted without anomalies and test via pacing system analyzer (psa), however, when ra lead was placed in the right ventricular (rv) lead port of the header a small blips or non physiologic pulses on the ra channel was noted.The ra lead terminal was removed and placed back on the psa with normal tracing, however, when placed back in the ra port of the device baseline blips still present and not oversensed.Furthermore, the impedance and sensing were normal.It was then confirmed that the anomaly was related to the terminal pin when rv lead was placed in the ra port and there were no blips of noise were seen.This ra lead was replaced with the same model, not implanted and will be returned for analysis.No adverse patient effects were reported.

• 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: 50946220
• Report Number: 2124215-2026-51948
• Device Sequence Number: 9499618
• Product Code: NVN
• UDI-Device Identifier: 00802526604577
• UDI-Public: (01)00802526604577(17)280719
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: Health Professional
• Device Model Number: 7841
• Device Catalogue Number: 7841
• Device Lot Number: 1807848
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 07/20/2026
• 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: 79 YR
• Patient Sex: Unknown