MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number	G146
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Data Problem (3196)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) showed the clock off one hour which was related to daylight savings time, so the device was working as expected.Furthermore, the device had a syncopal episode with no report of shock and other ventricular arrhythmia episode which had anti-tachycardia pacing (atp) and an electric shock.The electrogram showed device operating as programmed and recent lead tests are within normal limits.The crt-d remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) showed the clock off one hour which was related to daylight savings time, so the device was working as expected.Furthermore, the device had a syncopal episode with no report of shock and other ventricular arrhythmia episode which had anti-tachycardia pacing (atp) and an electric shock.The electrogram showed device operating as programmed and recent lead tests are within normal limits.The crt-d remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.\ \ a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.\ \ a risk review was completed and confirmed that the event of data issue was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.\ \ review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.\ \ based on a thorough review of the reported complaint, the conclusion code no problem detected was selected.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) showed the clock off one hour which was related to daylight savings time, so the device was working as expected.Furthermore, the device had a syncopal episode with no report of shock and other ventricular arrhythmia episode which had anti-tachycardia pacing (atp) and an electric shock.The electrogram showed device operating as programmed and recent lead tests are within normal limits.The crt-d has been explanted due to normal battery depletion and has been returned for analysis without additional allegations.No additional adverse patient effects were reported.

• Brand Name: INOGEN X4 CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 19265921
• Report Number: 2124215-2024-28006
• Device Sequence Number: 12636258
• Product Code: NIK
• UDI-Device Identifier: 00802526534577
• UDI-Public: 00802526534577
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/28/2018
• Device Model Number: G146
• Device Catalogue Number: G146
• Device Lot Number: 373002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male