MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; IMPLANTABLE DEVICE

Model Number G148

Device Problems Pacing Problem (1439); Inaccurate Synchronization (1609)

Patient Problem Ventricular Fibrillation (2130)

Event Date 01/26/2024

Event Type  Injury  

Event Description

It was reported that during a ventricular tachycardia (vt) ablation procedure, what appeared to be weird pacing occurred that induced ventricular fibrillation (vf).An external defibrillator was used to convert the vf.Therapy from the cardiac resynchronization therapy defibrillator (crt-d) had been programmed off.Technical services (ts) was contacted, and ts discussed possible explanations such as if the ablation catheter was close to the left ventricular (lv) lead body, the high frequency energy could get capacitively coupled onto the lead conductors and transmit through the lead to the tip or pulse generator.The crt-d system remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that during a ventricular tachycardia (vt) ablation procedure, what appeared to be weird pacing occurred that induced ventricular fibrillation (vf).An external defibrillator was used to convert the vf.Therapy from the cardiac resynchronization therapy defibrillator (crt-d) had been programmed off.Technical services (ts) was contacted, and ts discussed possible explanations such as if the ablation catheter was close to the left ventricular (lv) lead body, the high frequency energy could get capacitively coupled onto the lead conductors and transmit through the lead to the tip or pulse generator.The crt-d system remains in service.No additional adverse patient effects were reported.

• Brand Name: INOGEN X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• 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: 18665769
• MDR Text Key: 334833129
• Report Number: 2124215-2024-07127
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2023
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 263810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• 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 Outcome(s): Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male