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

Model Number G146

Device Problem Interrogation Problem (4017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2023

Event Type  malfunction  

Event Description

It was reported that the patient received an external defibrillation shock as it was suffering from ventricular tachycardia (vt) that was below this cardiac resynchronization therapy defibrillator (crt-d) programmed therapy zone.After the shock, this crt-d was unable to be interrogated any longer with an integrated programmer.An external cardiac monitor showed pacing signals, meaning the device was still functioning.However, the physician plans to replace this crt-d as soon as the patient is in good condition.This crt-d remains in service and 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: 18682856
• MDR Text Key: 335092606
• Report Number: 2124215-2024-07786
• 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: 02/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/14/2021
• Device Model Number: G146
• Device Catalogue Number: G146
• Device Lot Number: 384214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male