MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G140

Device Problems Failure to Convert Rhythm (1540); Inaccurate Synchronization (1609)

Patient Problems Ventricular Fibrillation (2130); Electric Shock (2554)

Event Date 05/01/2022

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d), presented for a routine follow-up and had mentioned that the patient was hospitalized in may with ventricular fibrillation (vf).The episode showed anti-tachycardia pacing (atp) with five 41 joule shocks.The atp accelerated the vf and the device delivered four shocks without success, the fifth shock converted the vf rhythm, and the shock impedance was in range.The physician suspects that the ineffective shocks were not due to the device but possibly due to patient condition lamina.The atp pre-shock was disabled, and the plan is to perform an x-ray to evaluate the position of the lead coil at the next follow-up in the next six to eight months.No additional adverse patient effects were reported.This device and right ventricular lead remain in-service.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d), presented for a routine follow-up and had mentioned that the patient was hospitalized in may with ventricular fibrillation (vf).The episode showed anti-tachycardia pacing (atp) with five 41 joule shocks.The atp accelerated the vf and the device delivered four shocks without success, the fifth shock converted the vf rhythm, and the shock impedance was in range.The physician suspects that the ineffective shocks were not due to the device but possibly due to patient condition lamina.The atp pre-shock was disabled, and the plan is to perform an x-ray to evaluate the position of the lead coil at the next follow-up in the next six to eight months.No additional adverse patient effects were reported.This device and right ventricular lead remain in-service.

• Brand Name: INOGEN CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH 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: 16127419
• MDR Text Key: 306972863
• Report Number: 2124215-2022-56309
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534539
• UDI-Public: 00802526534539
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2019
• Device Model Number: G140
• Device Catalogue Number: G140
• Device Lot Number: 488517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 01/16/2023
• Supplement Dates FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization