MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G148

Device Problems Premature Discharge of Battery (1057); Telemetry Discrepancy (1629); Device Displays Incorrect Message (2591)

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

Event Date 10/01/2021

Event Type  Injury  

Event Description

It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirmed fc1003.The device hardware was not detecting the loss of battery energy.Hence, the battery status indicators were not reflecting the depletion condition and were inaccurate.The device is malfunctioning and replacement is recommended.To date, the device remains in service.No 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 device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirmed fc1003.The device hardware was not detecting the loss of battery energy.Hence, the battery status indicators were not reflecting the depletion condition and were inaccurate.The device is malfunctioning, and replacement is recommended.To date, the device remains in service.No adverse patient effects were reported.Additional information indicated that data analysis confirmed that the device power consumption is increasing in a gradual fashion.This appears consistent with capacitor degradation due to hydrogen gas content in the sealed pulse generator (pg) atmosphere.

Manufacturer Narrative

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

Event Description

It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirmed fc1003.The device hardware was not detecting the loss of battery energy.Hence, the battery status indicators were not reflecting the depletion condition and were inaccurate.The device is malfunctioning, and replacement is recommended.To date, the device remains in service.No adverse patient effects were reported.Additional information indicated that data analysis confirmed that the device power consumption is increasing in a gradual fashion.This appears consistent with capacitor degradation due to hydrogen gas content in the sealed pulse generator (pg) atmosphere.This supplemental report is being filed as additional information was received that reported the sales representative had difficulty interrogating the device.At this time, the device remains in service.No adverse patient effects were reported.Additional information was received that this device was explanted and replaced with a new device, which 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 device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirmed fc1003.The device hardware was not detecting the loss of battery energy.Hence, the battery status indicators were not reflecting the depletion condition and were inaccurate.The device is malfunctioning, and replacement is recommended.To date, the device remains in service.No adverse patient effects were reported.Additional information indicated that data analysis confirmed that the device power consumption is increasing in a gradual fashion.This appears consistent with capacitor degradation due to hydrogen gas content in the sealed pulse generator (pg) atmosphere.This supplemental report is being filed as additional information was received that reported the sales representative had difficulty interrogating the device.At this time, the device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: INOGEN X4 CRT-D
• Type of Device: 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: 14291467
• MDR Text Key: 291229128
• Report Number: 2124215-2022-14094
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/04/2017
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 141336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2015
• 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): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male