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

Model Number	G146
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the field presentative had difficulty interrogation this patient with a cardiac resynchronization therapy defibrillator (crt-d).Additionally, the patient has a left ventricular assist device (lvad).After several attempts of troubleshooting the representative was able to successfully interrogate the device after the patient raised her arm above her head.Upon interrogation, the device was found to be at end of life (eol).At this time, the device remains in service.No adverse patient effects were reported.Additional information was received which reported that the health care professional (hcp) had difficulty interrogating the device.A magnet was used, and they heard a constant tone which indicates that tachy therapy is programmed off which is typical for lvad patients at this facility.Technical services suspects electromagnetic interference (emi) from the lvad and provided troubleshooting options.At this time, the device remains in service.No adverse patient effects were reported.

• Brand Name: INOGEN X4 CRT-D
• Common Device Name: 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: 21058540
• Report Number: 2124215-2025-00044
• Device Sequence Number: 18159489
• Product Code: NIK
• UDI-Device Identifier: 00802526534577
• UDI-Public: 00802526534577
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/10/2016
• Device Model Number: G146
• Device Catalogue Number: G146
• Device Lot Number: 102620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/02/2025
• Date Device Manufactured: 04/23/2014
• 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
• Patient Age: 72 YR
• Patient Sex: Female