MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	G146
Medical Device Problem Codes	Failure to Charge (1085); Failure to Convert Rhythm (1540); Failure to Read Input Signal (1581); Under-Sensing (1661); Low impedance (2285); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device has been returned for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this patient passed away.The patients obituary indicates the patient passed away at home.Boston scientific technical services (ts) reviewed data from the patients implanted cardiac resynchronization therapy defibrillator (crt-d) device.There was a stored episode where the device provided three rounds of anti-tachycardia pacing (atp) therapy followed by a 41 joule device shock for a ventricular arrhythmia.The device shock exhibited an associated shock fault due to a low out of range right ventricular (rv) lead shock impedance value.The shock impedance value was reported as less than 20 ohms, which means the measured shock impedance was less than the minimum value, too low for a numerical result.The device subsequently attempted 26 times to charge for an additional shock, but all attempts failed, exhibiting shock faults and aborted shock attempts due to high voltage and the episode ended.There were 10 subsequent non-sustained ventricular episodes where no device therapy was provided.Ts noted that these stored episodes showed an agonal rhythm and functional undersensing of the degrading electrical signal.Boston scientific engineering also reviewed the stored episode with device therapy.Engineering indicated that the 41 joule shock appears to have damaged the crt-d device resulting in the numerous subsequent high voltage faults during attempted charging.The internal damage resulted in energy leakage during charging which the device sensed as external energy, even though there were no external shock attempts.It was recommended that the crt-d device and rv lead be returned to boston scientific for analysis.The crt-d device and rv lead were returned and have been received at boston scientific.
Additional Manufacturer Narrative
The device has been returned for analysis.This report will be updated upon completion of analysis.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A review of device memory confirmed that the device delivered a 41 joule shock but exhibited an associated shock fault due to a low out of range right ventricular (rv) lead shock impedance value of less than 20 ohms.Device memory also confirmed there were numerous high voltage faults during subsequent attempts by the device to charge.Microscopic inspection of the device noted an electrical arcing mark on the outer device case just below the device header.An x-ray of the device indicated that the internal plasma fuse component was blown open.The device is unable to charge with an open plasma fuse.The proximal segment of the associated rv lead was also returned for analysis and there was observed inner insulation, outer insulation, and conductor damage consistent with the lead being crushed.There was no evidence observed of electrical arcing damage or melted metal on the lead segment.However, it is likely, based on the electrical arcing mark observed on the outer case of the device and the observed damage of the returned rv lead segment, that electrical arcing did occur in the damaged lead area during the attempted device shock and resulted in damage to the internal device plasma fuse.Laboratory analysis indicates the reported clinical observations were caused by damaged lead insulation and lead conductors, which then caused internal damage to the device plasma fuse during the device shock.
Event or Problem Description
It was reported that this patient passed away.The patients obituary indicates the patient passed away at home.Boston scientific technical services (ts) reviewed data from the patients implanted cardiac resynchronization therapy defibrillator (crt-d) device.There was a stored episode where the device provided three rounds of anti-tachycardia pacing (atp) therapy followed by a 41 joule device shock for a ventricular arrhythmia.The device shock exhibited an associated shock fault due to a low out of range right ventricular (rv) lead shock impedance value.The shock impedance value was reported as less than 20 ohms, which means the measured shock impedance was less than the minimum value, too low for a numerical result.The device subsequently attempted 26 times to charge for an additional shock, but all attempts failed, exhibiting shock faults and aborted shock attempts due to high voltage and the episode ended.There were 10 subsequent non-sustained ventricular episodes where no device therapy was provided.Ts noted that these stored episodes showed an agonal rhythm and functional undersensing of the degrading electrical signal.Boston scientific engineering also reviewed the stored episode with device therapy.Engineering indicated that the 41 joule shock appears to have damaged the crt-d device resulting in the numerous subsequent high voltage faults during attempted charging.The internal damage resulted in energy leakage during charging which the device sensed as external energy, even though there were no external shock attempts.It was recommended that the crt-d device and rv lead be returned to boston scientific for analysis.The crt-d device and rv lead were returned and have been received at boston scientific.

• Brand Name: INOGEN X4 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: 17455009
• Report Number: 2124215-2023-41397
• Device Sequence Number: 7382706
• Product Code: NIK
• UDI-Device Identifier: 00802526534577
• UDI-Public: 00802526534577
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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: 04/10/2017
• Device Model Number: G146
• Device Catalogue Number: G146
• Device Lot Number: 370091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR
• Patient Sex: Male