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); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) experienced atrial fibrillation (af) with normal conduction, but the rate sped up, and atp was delivered; the arrhythmia broke shortly after.Then a second episode occurred, where the patient again went into af with normal conduction, rate sped up, and received atp, which did not work, and then a shock was delivered, which did not break the rhythm, but the arrhythmia slowed out of a treatment zone.It was questioned if this was af with rvr or a dual arrhythmia, possible inappropriate therapy.Additional information was received that this device was suspected to deliver 9 bursts of atp and one electric shock for what appears to be af with rapid ventricular response (rvr).The episode self-terminated.No additional adverse patient effects were reported.This device 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 ; +1(651)582-6168
• MDR Report Key: 23305990
• Report Number: 2124215-2025-73559
• Device Sequence Number: 4967437
• Product Code: LWS
• UDI-Device Identifier: 00802526534263
• UDI-Public: (01)00802526534263(17)170727
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

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: 07/27/2017
• Device Model Number: D143
• Device Catalogue Number: D143
• Device Lot Number: 201033
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/04/2026
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2015
• 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: 76 YR
• Patient Sex: Male