MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; IMPLANTABLE DEVICE

Model Number G148

Device Problems High impedance (1291); Over-Sensing (1438); Connection Problem (2900)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and right atrial (ra) lead exhibited high out-of-range pacing impedances measuring greater than 3000 ohms.It was also noted there have been several atrial tachy response episodes which was due to oversensing of the respiratory rate trend (rrt) signal.Patient was brought into the clinic for further evaluation and the respiratory rate trend feature was turned off.When rrt was turned off there was no noise observed however, ra pacing impedances were still fluctuating from 491-3000 ohms.Isometric testing was performed and they could not reproduce the noise.Boston scientific technical services (ts) reviewed the episode and it appears there is a non-physiologic signal on both the ra and the shock electrogram.Ts believes it could be possible electromagnetic interference and discussed other possible causes.Ts recommended to bring the patient if for another follow-up and to evaluate the ra lead and reset the alert condition.At this time, this crt and ra lead remains in service.No adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and right atrial (ra) lead exhibited high out-of-range pacing impedances measuring greater than 3000 ohms.It was also noted there have been several atrial tachy response episodes which was due to oversensing of the respiratory rate trend (rrt) signal.Patient was brought into the clinic for further evaluation and the respiratory rate trend feature was turned off.When rrt was turned off there was no noise observed however, ra pacing impedances were still fluctuating from 491-3000 ohms.Isometric testing was performed and they could not reproduce the noise.Boston scientific technical services (ts) reviewed the episode and it appears there is a non-physiologic signal on both the ra and the shock electrogram.Ts believes it could be possible electromagnetic interference and discussed other possible causes.Ts recommended to bring the patient if for another follow-up and to evaluate the ra lead and reset the alert condition.At this time, this crt and ra lead remains in service.No adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and right atrial (ra) lead exhibited high out-of-range pacing impedances measuring greater than 3000 ohms.It was also noted there have been several atrial tachy response episodes which was due to oversensing of the respiratory rate trend (rrt) signal.Patient was brought into the clinic for further evaluation and the respiratory rate trend feature was turned off.When rrt was turned off there was no noise observed however, ra pacing impedances were still fluctuating from 491-3000 ohms.Isometric testing was performed and they could not reproduce the noise.Boston scientific technical services (ts) reviewed the episode and it appears there is a non-physiologic signal on both the ra and the shock electrogram.Ts believes it could be possible electromagnetic interference and discussed other possible causes.Ts recommended to bring the patient if for another follow-up and to evaluate the ra lead and reset the alert condition.At this time, this crt-d and ra lead remains in service.No adverse patient effects were reported.This supplemental report is being filed as this cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced successfully.Additionally, there was set screw issues.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and right atrial (ra) lead exhibited high out-of-range pacing impedances measuring greater than 3000 ohms.It was also noted there have been several atrial tachy response episodes which was due to oversensing of the respiratory rate trend (rrt) signal.Patient was brought into the clinic for further evaluation and the respiratory rate trend feature was turned off.When rrt was turned off there was no noise observed however, ra pacing impedances were still fluctuating from 491-3000 ohms.Isometric testing was performed and they could not reproduce the noise.Boston scientific technical services (ts) reviewed the episode and it appears there is a non-physiologic signal on both the ra and the shock electrogram.Ts believes it could be possible electromagnetic interference and discussed other possible causes.Ts recommended to bring the patient if for another follow-up and to evaluate the ra lead and reset the alert condition.At this time, this crt-d and ra lead remains in service.No adverse patient effects were reported.This supplemental report is being filed as this cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced successfully.Additionally, there was set screw issues.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has been returned to boston scientific, and investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to intermittent increases in impedance measurements.Engineering analysis and testing of returned products has identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time.This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements.Please refer to the description field for more information regarding the specific circumstances of this event.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.

• Brand Name: INOGEN X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• 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: 11104973
• MDR Text Key: 224827566
• Report Number: 2124215-2020-26447
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/13/2019
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 175183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male