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

Model Number G148

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

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

Event Date 12/20/2023

Event Type  Injury  

Event Description

It was reported that this device has reached elective replacement indicator (eri) and emitted a beeping tone.The device battery dropping faster than expected.Additional information received which indicated that the device went from 10 months down to 3 months battery remaining.As of this time, this 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.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.Correction to field f10.Device codes.

Event Description

It was reported that this device has reached elective replacement indicator (eri) and emitted a beeping tone.The device battery dropping faster than expected.Additional information received which indicated that the device went from 10 months down to 3 months battery remaining.As of this time, this device remains in service.No adverse patient effects were reported.Additional information received indicates that this device was surgically explanted due to normal battery depletion (nbd) and replaced.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: 18575962
• MDR Text Key: 334751945
• Report Number: 2124215-2024-03754
• 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
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/26/2016
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 127565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2014
• 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: 56 YR
• Patient Sex: Male