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

Model Number	D143
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Inaccurate Synchronization (1609)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) presented with a rhythm that the physician determined was a slow ventricular tachycardia (vt).A burst of commanded anti-tachycardia pacing (atp) was delivered, followed by burst of device driven atp, resulting in the rhythm accelerating into ventricular fibrillation (vf).Then, this device successfully delivered a shock and converted the rhythm.Technical services (ts) was contacted and analyzed the episode data and noted the device appeared to be operating as programmed.This icd remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) presented with a rhythm that the physician determined was a slow ventricular tachycardia (vt).A burst of commanded anti-tachycardia pacing (atp) was delivered, followed by burst of device driven atp, resulting in the rhythm accelerating into ventricular fibrillation (vf).Then, this device successfully delivered a shock and converted the rhythm.Technical services (ts) was contacted and analyzed the episode data and noted the device appeared to be operating as programmed.This icd remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The device remains in service; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.A risk review was completed and confirmed that the event of rhythm acceleration was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.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 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23304281
• Report Number: 2124215-2025-73501
• Device Sequence Number: 18637078
• Product Code: LWS
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: 08/12/2021
• Device Model Number: D143
• Device Catalogue Number: D143
• Device Lot Number: 218543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 05/05/2026
• Date Device Manufactured: 08/20/2019
• 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: Life Threatening; Other
• Patient Age: 67 YR
• Patient Sex: Male