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); Battery Problem (2885); Noise, Audible (3273)

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

Event Date 11/07/2022

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Additionally, the device was also beeping.Data analysis validated low voltage fault and confirmed that the power consumption was increasing in a gradual fashion.This appears consistent with capacitor degradation due to hydrogen gas content in the sealed pg atmosphere.Device replacement or reassessment was 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Additionally, the device was also beeping.Data analysis validated low voltage fault and confirmed that the power consumption was increasing in a gradual fashion.This appears consistent with capacitor degradation due to hydrogen gas content in the sealed pg atmosphere.Device replacement or reassessment was recommended.To date, the device remains in service.No adverse patient effects were reported.Additional information was obtained which indicated that the device was surgically explanted due to error code and premature battery depletion (pbd).New device was placed.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.The product has been received for analysis.Upon completion of the failure analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.The returned cardiac resynchronization therapy defibrillator (crt-d) was analyzed and a review of the device memory confirmed that a low voltage alert, code 1003, was recorded.The battery voltage was lower than expected, but still supported full device function.Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a high current condition associated with a compromised low voltage capacitor connected to the device battery.Low voltage capacitors are used in the high voltage charging operation in order to facilitate fast charge times.The behavior of these capacitors resulted in a high current drain, which was depleting the device battery faster than normal.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Additionally, the device was also beeping.Data analysis validated low voltage fault and confirmed that the power consumption was increasing in a gradual fashion.This appears consistent with capacitor degradation due to hydrogen gas content in the sealed pg atmosphere.Device replacement or reassessment was recommended.To date, the device remains in service.No adverse patient effects were reported.Additional information was obtained which indicated that the device was surgically explanted due to error code and premature battery depletion (pbd).New device was placed.No additional adverse patient effects were reported.

• 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: 15804220
• MDR Text Key: 303715529
• Report Number: 2124215-2022-47394
• Device Sequence Number: 1
• Product Code: NIK
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/02/2019
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 180016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2017
• 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): Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female