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

Model Number	D142
Medical Device Problem Codes	High impedance (1291); Pacing Problem (1439); Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574); Under-Sensing (1661)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Loss of consciousness (2418)
Date of Event	09/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) was in a dual arrythmia and was found unconscious and not breathing.Technical services (ts) was called for further review of the stored episode.It was noted that the right ventricular (rv) lead exhibited high out of range shock impedances.Upon review, the presenting electrogram (egm) showed patient was in a dual arrhythmia and the device delivered bursts of anti-tachycardia pacing (atp) and shocks.Therapy was exhausted.The shocks were unable to convert the arrhythmia.Ts reviewed the daily threshold and impedance measurements trend report and confirmed the rv lead shock impedances were greater than 125 ohms and had been gradually increasing over the years.It was noted that 911 was contacted by patient advocate.No additional adverse patient effects were reported.This icd and rv lead remain in service.
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 (Non-Crt)
• 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: 50246155
• Report Number: 2124215-2026-43631
• Device Sequence Number: 10072976
• Product Code: LWS
• UDI-Device Identifier: 00802526534249
• UDI-Public: (01)00802526534249(17)220129
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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: 01/29/2022
• Device Model Number: D142
• Device Catalogue Number: D142
• Device Lot Number: 577783
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 02/07/2020
• 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; Life Threatening
• Patient Age: 68 YR
• Patient Sex: Male