MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Model Number	D143
Medical Device Problem Codes	Pacing Problem (1439); Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	06/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the health care professional (hcp) requested a review of tachycardia episodes on this implantable cardioverter defibrillator (icd).Technical services (ts) reviewed the stored episodes and noted the episodes appeared atrial driven with 1:1 rhythm that were successfully terminated with anti-tachycardia pacing (atp).Ts could not rule out that pacing configuration initiated the atrial arrythmia and reprogramming options were discussed.No adverse patient effects were reported.This icd remains in service.

• 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25771539
• Report Number: 2124215-2026-36941
• Device Sequence Number: 10541164
• Product Code: LWS
• UDI-Device Identifier: 00802526534263
• UDI-Public: (01)00802526534263(17)170303
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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: 03/03/2017
• Device Model Number: D143
• Device Catalogue Number: D143
• Device Lot Number: 198830
• 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: 06/13/2026
• Initial Report FDA Received Date: 07/09/2026
• Date Device Manufactured: 03/03/2015
• 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: Other
• Patient Age: 63 YR
• Patient Sex: Male