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

Model Number	D141
Medical Device Problem Codes	Pacing Problem (1439); Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) and requested further review of this implantable cardioverter defibrillator (icd) stored ventricular episode to confirm device operation.Upon review, the ventricular episode showed that the patient was in a supraventricular tachycardia (svt) rhythm.The icd inappropriately delivered eight bursts of anti-tachycardia pacing (atp) and six shocks in attempt to convert the rhythm.Therapy was exhausted and the patient remained in svt rhythm.Ts discussed programming optimization options with the hcp.At this time, the icd remains in service.No additional adverse patient effects were reported.

• Brand Name: INOGEN EL ICD VR
• 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: 21531992
• Report Number: 2124215-2025-13816
• Device Sequence Number: 20797716
• Product Code: LWS
• UDI-Device Identifier: 00802526534225
• UDI-Public: 00802526534225
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2025

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: 07/25/2021
• Device Model Number: D141
• Device Catalogue Number: D141
• Device Lot Number: 205467
• 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: 02/21/2025
• Initial Report FDA Received Date: 03/05/2025
• Date Device Manufactured: 08/12/2019
• 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: Other
• Patient Age: 58 YR
• Patient Sex: Male