MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	G140
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an alert on this cardiac resynchronization therapy defibrillator (crt-d) for atrial pacing impedance measurements being out-of-range.Technical services (ts) analyzed the presenting electrogram (egm) and found that there were measurements that were high out-of-range.Ts advised further monitoring of this situation.No additional adverse patient effects were reported.The right atrial (ra) lead is not manufactured by boston scientific.Currently, this crt-d remains in service.
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 impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.
Event or Problem Description
It was reported that there was an alert on this cardiac resynchronization therapy defibrillator (crt-d) for atrial pacing impedance measurements being out-of-range.Technical services (ts) analyzed the presenting electrogram (egm) and found that there were measurements that were high out-of-range.Ts advised further monitoring of this situation.No additional adverse patient effects were reported.The right atrial (ra) lead is not manufactured by boston scientific.Currently, this crt-d remains in service.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 impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.
Event or Problem Description
It was reported that there was an alert on this cardiac resynchronization therapy defibrillator (crt-d) for atrial pacing impedance measurements being out-of-range.Technical services (ts) analyzed the presenting electrogram (egm) and found that there were measurements that were high out-of-range.Ts advised further monitoring of this situation.No additional adverse patient effects were reported.The right atrial (ra) lead is not manufactured by boston scientific.Currently, this crt-d remains in service.According to additional information, this crt-d was explanted at scheduled generator change out for normal battery depletion.A new crt-d was placed at this time.No adverse patient effects were reported outside of the replacement procedure.This product has been returned to boston scientific for further investigation.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Pin gage testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.The associated investigation also 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.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.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 impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.

• Brand Name: INOGEN? CRT-D
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH 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 ; 6515826168
• MDR Report Key: 17342902
• Report Number: 2124215-2023-37799
• Device Sequence Number: 20476292
• Product Code: NIK
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2026

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: 07/10/2017
• Device Model Number: G140
• Device Catalogue Number: G140
• Device Lot Number: 479505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 08/02/2023; 12/31/2025
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/03/2023; 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2015
• 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: 84 YR
• Patient Sex: Female