MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number	G146
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crtd) exhibited high out of range shock impedance measurements greater than 135 ohms.It was also noted that the crtd is at elective replacement indicator (eri) and a change out was planned.Additionally, no noise could be seen, and right ventricular pace impedance was within normal limits.Technical services (ts) recommended a max energy r wave synch shock and if a code 1005 indicative of an open circuit condition during shock delivery is recorded then lead replacement was recommended, however if after the shock the shocking impedances are within range the physician can consider monitoring the lead.This crtd remains in service.No adverse patient effects were reported.Additional information was received, this crtd was explanted due to normal battery depletion and defibrillation threshold (dft) test was performed to assess shock lead impedances.This device was successfully replaced and the right ventricular lead remains in service.No additional adverse patient effects were reported.This product was returned and is pending analysis.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, 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.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crtd) exhibited high out of range shock impedance measurements greater than 135 ohms.It was also noted that the crtd is at elective replacement indicator (eri) and a changeout was planned.Additionally, no noise could be seen, and right ventricular pace impedance was within normal limits.Technical services (ts) recommended a max energy r wave synch shock and if a code 1005 indicative of an open circuit condition during shock delivery is recorded then lead replacement was recommended, however if after the shock the shocking impedances are within range the physician can consider monitoring the lead.This crtd remains in service.No adverse patient effects were reported.Additional information was received, this crtd was explanted due to normal battery depletion and defibrillation threshold (dft) test was performed to assess shock lead impedances.This device was successfully replaced and the right ventricular lead remains in service.No additional adverse patient effects were reported.This product was returned and is pending analysis.

• Brand Name: INOGEN X4 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: 19710580
• Report Number: 2124215-2024-42522
• Device Sequence Number: 20959005
• Product Code: NIK
• UDI-Device Identifier: 00802526534577
• UDI-Public: 00802526534577
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2024

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: 09/29/2017
• Device Model Number: G146
• Device Catalogue Number: G146
• Device Lot Number: 371455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2015
• 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: 35 YR
• Patient Sex: Male