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

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.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.External visual inspection of the device revealed no anomalies.Review of the device memory confirmed that a low voltage alert was recorded.Although the device memory diagnostics demonstrated that the daily battery voltage measurements displayed an irregular pattern of discharge, the battery voltage level upon receipt in the laboratory was sufficient to ensure therapy availability/delivery while the device was implanted.The device case was then opened to facilitate analysis of the internal components.The battery was separated from the other device electronics and the overall current draw of the circuitry was measured.A normal current drain was observed within the circuitry.Collectively, the pattern of irregular daily battery voltage measurements in conjunction with normal power levels and device hybrid current draw is consistent with behavior of devices where a latent current leakage path has occurred within the battery itself, resulting in a partial depletion of the battery.This behavior is caused by a latent electrical leakage path that develops over time between the anode and cathode within the device battery.In certain circumstances, lithium metal ions can re-plate to form clusters that may result in an internal current leakage.A design enhancement was implemented in 2013 to enlarge the physical barrier between the electrode layers to prevent current leakage in the area of the battery that is most often affected by this behavior.

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.

• 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: 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,Followup
• Report Date: 05/01/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 57 YR
• Patient Sex: Male