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

Model Number	G140
Medical Device Problem Codes	Failure to Convert Rhythm (1540); Inaccurate Synchronization (1609)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Electric Shock (2554)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2124215-2022-56309
• Device Sequence Number: 14252947
• Product Code: NIK
• UDI-Device Identifier: 00802526534539
• UDI-Public: 00802526534539
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P010012/S341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown