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

Model Number	G141
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited high out of range shock impedance measurements, measuring greater than 125 ohms.Technical services (ts) recommended monitoring the impedance measurements.No adverse patient effects were reported.This crt-d remains in service.Additional information was received that this crt-d was explanted and replaced due to normal battery depletion (nbd).No adverse patient effects were reported.This crt-d has not returned for analysis.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
The device was discarded by the facility; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited high out of range shock impedance measurements, measuring greater than 125 ohms.Technical services (ts) recommended monitoring the impedance measurements.No adverse patient effects were reported.This crt-d remains in service.Additional information was received that this crt-d was explanted and replaced due to normal battery depletion (nbd).No adverse patient effects were reported.This crt-d has not returned for analysis.

• 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: 24512898
• Report Number: 2124215-2026-12055
• Device Sequence Number: 16015939
• Product Code: NIK
• UDI-Device Identifier: 00802526534553
• UDI-Public: (01)00802526534553(17)170117
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/17/2017
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 107507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/08/2026
• Date Device Manufactured: 01/17/2015
• 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
• Patient Age: 73 YR
• Patient Sex: Male