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

Model Number G141

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Pacing Problem (1439)

Patient Problem Asystole (4442)

Event Date 02/14/2023

Event Type  Injury  

Event Description

This rv lead had exhibited noise and oversensing resulting in pacing inhibition for greater than 2 seconds of asystole for a pacemaker dependent patient, requiring intervention.Additionally, report of intentional off label use by plugging this rv lead into the lv port and programming lv sensing off and plugging the lv lead into the rv port.No additional adverse patient effects were reported.It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system was exhibiting suspected pacing inhibition above five seconds and high out of range right ventricular (rv) lead impedance measurements.Noise was noted from a non sustained ventricular tachycardia episode which was identified to be correlated with patient surgery.Technical services (ts) was consulted and recommended system testing options.This crt-d system remains in service.The patient will continue to be monitored.No adverse patient effects were reported.

• Brand Name: INOGEN CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 16650707
• MDR Text Key: 312397942
• Report Number: 2124215-2023-15088
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534553
• UDI-Public: 00802526534553
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2023

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: 01/15/2017
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 107458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2015
• 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; Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male