MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? EL ICD DR; Implantable Cardioverter Defibrillator (ICD)

Model Number	D143
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) for a consult review of the implantable cardioverter defibrillator (icd) stored episode due to concerns of oversensing noise.The hcp stated that the episode occurred while the patient was exercising.Upon review, the presenting electrogram (egm) showed oversensed noise that appears to be inhibiting pacing.Its noted patient is not pacing dependent.Ts also noted a drop in right ventricular (rv) lead pacing impedance from 900 to 600ohms which are still considered to be within normal limits (wnl).Ts recommended an in clinic visit for isometric evaluation of the lead.Subsequently, a revision procedure was performed.The icd was explanted and replaced with a new device.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: INOGEN? EL ICD DR
• Common Device Name: Implantable Cardioverter Defibrillator (ICD)
• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50935349
• Report Number: 2124215-2026-51729
• Device Sequence Number: 21514114
• Product Code: LWS
• UDI-Device Identifier: 00802526534263
• UDI-Public: (01)00802526534263(17)170410
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/10/2017
• Device Model Number: D143
• Device Catalogue Number: D143
• Device Lot Number: 199334
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 04/10/2015
• 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 Age: 70 YR
• Patient Sex: Female