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

Model Number G148

Device Problems Pacing Problem (1439); Off-Label Use (1494); Inaccurate Synchronization (1609); Under-Sensing (1661)

Patient Problem Arrhythmia (1721)

Event Date 01/04/2024

Event Type  Injury  

Event Description

It was reported that undersensing and inappropriate pacing was noted on this cardiac resynchronization therapy defibrillator (crt-d).Right ventricle (rv) sensing occurred in the blanking period, which then lead rv pacing being provided on the t-wave.As a result, the patient had an episode of ventricular tachycardia (vt).It was noted that the patient has a concomitant left ventricular assist device implanted.Technical services (ts) reviewed the episodes and recommended adjusting the sensitivity and blanking programming.This patient is expected to follow-up in clinic, and this investigation will be updated should further information becomes available.This crt-d remains in-service.No adverse patient effects were reported.

• Brand Name: INOGEN X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• 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: 18494284
• MDR Text Key: 332678028
• Report Number: 2124215-2024-01265
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 298509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other