MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number	G140
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Data Problem (3196)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered multiple shocks during different episodes while the patient was engaging in physical activity.Technical services (ts) was consulted, and it was found that the device was in end of life (eol) status; therefore, no data was available for review.Ts suspected that the shocks delivered were inappropriate.This crt-d was explanted due to normal battery depletion.This device was successfully replaced.No adverse patient effects were reported.At this time, this crt-d has not been returned to boston scientific.

• Brand Name: INOGEN? CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 22084966
• Report Number: 2124215-2025-33990
• Device Sequence Number: 6926412
• Product Code: NIK
• UDI-Device Identifier: 00802526534539
• UDI-Public: (01)00802526534539(17)170320
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• 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): 05/26/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/20/2017
• Device Model Number: G140
• Device Catalogue Number: G140
• Device Lot Number: 477863
• 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: 05/13/2025
• Initial Report FDA Received Date: 05/26/2025
• Date Device Manufactured: 03/20/2015
• 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: 77 YR
• Patient Sex: Male