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

Model Number	G146
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited oversensing of noise on both the right atrial (ra) lead and right ventricular (rv) leads.Boston scientific technical services (ts) was consulted and discussed the noise may be from a medical procedure and/or electromagnetic interference (emi).Additionally, undersensing was also observed.Further review was recommended.No adverse patient effects were reported.At this time, this device remains in service.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited oversensing of noise on both the right atrial (ra) lead and right ventricular (rv) leads.Boston scientific technical services (ts) was consulted and discussed the noise may be from a medical procedure and/or electromagnetic interference (emi).Additionally, undersensing was also observed.Further review was recommended.No adverse patient effects were reported.At this time, this device remains in service.

• 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: 20360035
• Report Number: 2124215-2024-61925
• Device Sequence Number: 12783844
• 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): 10/18/2024

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: 10/01/2017
• Device Model Number: G146
• Device Catalogue Number: G146
• Device Lot Number: 371543
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/18/2024
• Date Device Manufactured: 10/01/2015
• 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: 64 YR
• Patient Sex: Female