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

Model Number	G148
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited high out of range shock lead impedances on the right ventricular (rv) lead.Technical services (ts) noted there was not enough data to know if this was a gradual increase.The crt-d was nearing the elective replacement indicator (eri), so ts recommended potential reprogramming and advised the physician to consider the rv lead replacement when the device does reach end of life (eol).The crt-d and rv lead remain in service.No 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: 25368152
• Report Number: 2124215-2026-29527
• Device Sequence Number: 13274040
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: (01)00802526534591(17)170527
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• 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
• Report Date (Section B): 06/02/2026

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: 05/27/2017
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 134561
• 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: 05/04/2026
• Initial Report FDA Received Date: 06/02/2026
• Date Device Manufactured: 05/27/2015
• 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: 82 YR
• Patient Sex: Male