MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? CRT-D; cardiac resynchronization therapy defibrillator (CRT-D)

Model Number	G141
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited left ventricular (lv) lead high out of range pacing impedance measurements greater than 3000 ohms.Lead testing was performed and it showed no signs of a lead problem.Technical services (ts) was consulted, discussed possible spring contact issue and noted impedances had been fluctuating for a while.Ts suggested reprogramming options.This crt-d remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited left ventricular (lv) lead high out of range pacing impedance measurements greater than 3000 ohms.Lead testing was performed and it showed no signs of a lead problem.Technical services (ts) was consulted, discussed possible spring contact issue and noted impedances had been fluctuating for a while.Ts suggested reprogramming options.This crt-d remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent changes in impedance measurements with no conclusive evidence of a product performance issue or inadequate lead to device connection, please refer to the description for more information regarding the specific circumstances of this event.Engineering analysis and testing of returned products has determined that repeated, small movements of the lead terminal ring along with variances in the connection contact force and surface roughness can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurement.

• Brand Name: INOGEN? CRT-D
• Common Device Name: cardiac resynchronization therapy defibrillator (CRT-D)
• 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: 22794376
• Report Number: 2124215-2025-56453
• Device Sequence Number: 20993353
• Product Code: NIK
• UDI-Device Identifier: 00802526534553
• UDI-Public: (01)00802526534553(17)190116
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2026

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: 01/16/2019
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 119835
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 09/23/2025; 07/29/2026
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/25/2025; 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2017
• 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: 59 YR
• Patient Sex: Female