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

Model Number G148

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Data Problem (3196)

Patient Problem Electric Shock (2554)

Event Date 06/23/2023

Event Type  malfunction  

Event Description

It was reported that the health care professional (hcp) wanted to review a stored ventricular episode that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced.Upon review, it was found that the patient was in a true ventricular arrhythmia, which self-terminated, but the device shock therapy was already committed to being delivered, therefore, the device delivered an electric shock.The icd was operating as programmed.Boston scientific technical services (ts) discussed reprogramming options.This device remains in service.No additional adverse patient effects were reported.

• 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: 17262807
• MDR Text Key: 318686120
• Report Number: 2124215-2023-35228
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/26/2021
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 221494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2019
• 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 Age: 76 YR
• Patient Sex: Male