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

Model Number G146

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Asystole (4442)

Event Date 07/21/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a more than 2 seconds pause with pacing inhibition and over sensed noisy signals on all channels.Impedance values were stable in the year view.Similar noise without inhibition was observed at other atrial tachy response episode.Various procedures were recommended to determine the origin of the observed behavior.The field representative was able to recreate the noise when the patient moves arm across his chest, but no noise was observed on the lv lead.A chest x ray was recommended.The crt-d remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this system with a cardiac resynchronization therapy defibrillator (crt-d), right ventricular (rv) and right atrial (ra) leads recorded a more than 2 seconds pause with pacing inhibition and over sensed noisy signals on all channels.Impedance values were stable in the year view.Similar noise without inhibition was observed at other atrial tachy response episode.Various procedures were recommended to determine the origin of the observed behavior.The field representative was able to recreate the noise when the patient moves arm across his chest, but no noise was observed on the lv lead.A chest x ray was recommended.Following the troubleshooting that was done in-clinic with the assistance of tech support, it was decided that the patient would need an extraction of the affected leads.Patient was discharged with programming changes that would decrease the risk of pacing inhibition.Patient and staff were to coordinate.The field representative has not received any further information on the patient.The crt-d, rv and ra leads have been explanted at this time.No additional adverse patient effects were reported.

Event Description

It was reported that this system with a cardiac resynchronization therapy defibrillator (crt-d), right ventricular (rv) and right atrial (ra) leads recorded a more than 2 seconds pause with pacing inhibition and over sensed noisy signals on all channels.Impedance values were stable in the year view.Similar noise without inhibition was observed at other atrial tachy response episode.Various procedures were recommended to determine the origin of the observed behavior.The field representative was able to recreate the noise when the patient moves arm across his chest, but no noise was observed on the lv lead.A chest x ray was recommended.Following the troubleshooting that was done in-clinic with the assistance of tech support, it was decided that the patient would need an extraction of the affected leads.Patient was discharged with programming changes that would decrease the risk of pacing inhibition.Patient and staff were to coordinate.The field representative has not received any further information on the patient.The crt-d, rv and ra leads have been explanted at this time.The crt-d has been returned for analysis.No additional adverse patient effects were reported.

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 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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INOGEN X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (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: 16910072
• MDR Text Key: 314978506
• Report Number: 2124215-2023-23259
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534577
• UDI-Public: 00802526534577
• 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
• Report Date: 11/01/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/29/2017
• Device Model Number: G146
• Device Catalogue Number: G146
• Device Lot Number: 371456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 08/08/2023; 10/30/2023
• Supplement Dates FDA Received: 08/16/2023; 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2015
• 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: 59 YR
• Patient Sex: Male