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

Model Number G148

Device Problems Failure to Convert Rhythm (1540); Defibrillation/Stimulation Problem (1573); Inaccurate Synchronization (1609); Under-Sensing (1661); High Capture Threshold (3266)

Patient Problem Ventricular Fibrillation (2130)

Event Date 05/19/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system was unable to convert a ventricular arrhythmia via anti-tachycardia pacing (atp).As a result the delivered atp accelerated the rhythm from ventricular tachycardia (vt) to ventricular fibrillation (vf).Once the rhythm accelerated to vf, the system began undersensing the arrhythmia, therefore no shocks were delivered.The patient was then externally shocked and the rhythm was converted.The physician identified that the programmed right ventricular (rv) lead exhibited high thresholds and the sensing floor was too high.The rv lead was subsequently explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: INOGEN X4 CRT-D
• Type of Device: 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: 17175243
• MDR Text Key: 317627246
• Report Number: 2124215-2023-32255
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2020
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 199833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2018
• 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