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

Model Number G148

Device Problem Premature Discharge of Battery (1057)

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

Event Date 01/31/2024

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 code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed that the 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.Furthermore, a device replacement was recommended or reassessed battery status within 90 days.To date, this device remains in service.No adverse patient effects were reported.

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.Data analysis showed that the 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.Furthermore, a device replacement was recommended or reassessed battery status within 90 days.To date, this device remains in service.No adverse patient effects were reported.Additional information indicated that this device was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.If information is provided in the future, a supplemental report will be issued.

• 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: 18764536
• MDR Text Key: 336203626
• Report Number: 2124215-2024-10761
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2024

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: 07/02/2017
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 136369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2015
• 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 Age: 74 YR
• Patient Sex: Male