MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? EL ICD VR; implantable cardioverter defibrillator

Model Number	D140
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a review of the recorded episodes of this implantable cardioverter defibrillator (icd), an isolated noise oversensing episode was observed.Technical services (ts) noted that the noise was likely from electromagnetic interference during a procedure, since therapy was programmed off for the episode.No adverse patient effects were reported.This device remains in service.
Additional Manufacturer Narrative
This product remains implanted and has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• Brand Name: INOGEN? EL ICD VR
• Common Device Name: implantable cardioverter defibrillator
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50601131
• Report Number: 2124215-2026-45825
• Device Sequence Number: 13444752
• Product Code: LWS
• UDI-Device Identifier: 00802526534201
• UDI-Public: (01)00802526534201(17)191213
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: 12/13/2019
• Device Model Number: D140
• Device Catalogue Number: D140
• Device Lot Number: 232027
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 01/12/2018
• 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: 51 YR
• Patient Sex: Male