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

Model Number G148

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Pacing Problem (1439); Failure to Convert Rhythm (1540); Inaccurate Synchronization (1609); Unexpected Therapeutic Results (1631); Under-Sensing (1661); Low impedance (2285)

Patient Problem Ventricular Fibrillation (2130)

Event Date 12/23/2023

Event Type  Injury  

Event Description

It was reported that this system with a cardiac resynchronization therapy defibrillator (crt-d) and a right ventricular (rv) lead recorded an event in the ventricular tachycardia (vt) zone in which anti-tachycardia pacing (atp) was delivered and accelerated the rhythm to ventricular fibrillation (vf) zone.Additionally, electric shock therapy was delivered but failed to convert the rhythm several times.Furthermore, a redetection of the arrhythmia occurred but the charge diverted due to vf under sensing.The arrhythmia was re-detected and again, therapy failed to convert and under sensing of vf post-shock was observed with over pacing.Event therapy was exhausted at therapy zone.Finally, the vf was redetected, and more shocks were delivered, which again, failed to convert rhythm.It was noted that the patient was externally cardioverted successfully.Afterward, concerns of rv lead sensitivity were discussed.Old notes from the rv lead were found that showed loss of capture (loc) and low amplitude noise which was not over sensed.Additionally, rv pacing impedance was found low, out of range.It was also found that the patient had a similar event in the past, where a vf showed all therapy exhausted.Various programming and procedural options were suggested.The patient was admitted to the hospital and at this time the rv lead and the crt-d have been explanted.A new system was implanted at the same surgical procedure.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INOGEN X4 CRT-D
• Type of Device: 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: 18729661
• MDR Text Key: 335709119
• Report Number: 2124215-2024-09521
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• 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: 295148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Female