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

Model Number G148

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Low impedance (2285); Impedance Problem (2950); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2021

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 system with a cardiac resynchronization therapy defibrillator (crt-d), right atrial (ra) lead and right ventricular (rv) lead showed episodes of oversensed noise without impedance changes.Doing isometrics the noise was observed without being over sensed but the specific cause was not able to be determined.The device was reprogrammed and the patient has had more episodes since last follow up, therefore is being monitored.The system remains in service.No adverse patient effects were reported.Additional information was received mentioning that noise is still being seen on both channels, but the patient now reported beeping tones and there was an out-of-range (oor) pacing impedance alert.The beep for oor measurements is programmed on.It was recommended to turn the beeping off.The system remains in service at this time.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.The associated investigation determined that this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the description for more information regarding the specific circumstances of this event.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 atrial (ra) lead and right ventricular (rv) lead showed episodes of oversensed noise without impedance changes.Doing isometrics the noise was observed without being over sensed but the specific cause was not able to be determined.The device was reprogrammed and the patient has had more episodes since last follow up, therefore is being monitored.The system remains in service.No adverse patient effects were reported.Additional information was received mentioning that noise is still being seen on both channels, but the patient now reported beeping tones and there was a low out-of-range (oor) pacing impedance alert.The beep for oor measurements is programmed on.It was recommended to turn the beeping off.The system remains in service at this time, but they plan to refer for lead extraction and replacement.No adverse patient effects were reported.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 fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the description for more information regarding the specific circumstances of this event.

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 fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the description for more information regarding the specific circumstances of this event.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 atrial (ra) lead and right ventricular (rv) lead showed episodes of oversensed noise without impedance changes.Doing isometrics the noise was observed without being over sensed but the specific cause was not able to be determined.The device was reprogrammed and the patient has had more episodes since last follow up, therefore is being monitored.The system remains in service.No adverse patient effects were reported.Additional information was received mentioning that noise is still being seen on both channels, but the patient now reported beeping tones and there was an out-of-range (oor) pacing impedance alert.The beep for oor measurements is programmed on.It was recommended to turn the beeping off.The system remains in service at this time.No adverse patient effects were reported.

Event Description

It was reported that this system with a cardiac resynchronization therapy defibrillator (crt-d), right atrial (ra) lead and right ventricular (rv) lead showed episodes of oversensed noise without impedance changes.Doing isometrics the noise was observed without being over sensed but the specific cause was not able to be determined.The device was reprogrammed and the patient has had more episodes since last follow up, therefore was monitored.Additional information was received mentioning that noise is still being seen on both channels, but the patient now reported beeping tones and there was a low out-of-range (oor) pacing impedance alert.The beep for oor measurements is programmed on.It was recommended to turn the beeping off.At this time the system has been explanted at a surgical intervention.The crt-d is not expected to be returned for analysis as it was retained by the customer.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.The associated investigation determined that this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the description for more information regarding the specific circumstances of this event.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 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: 17507637
• MDR Text Key: 320854329
• Report Number: 2124215-2023-42950
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2023

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: 03/07/2016
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 102416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 08/16/2023; 08/29/2023; 12/08/2023
• Supplement Dates FDA Received: 08/20/2023; 09/01/2023; 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2014
• 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: 69 YR
• Patient Sex: Male