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

Model Number G148

Device Problems Over-Sensing (1438); Inaccurate Synchronization (1609)

Patient Problem Ventricular Tachycardia (2132)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

No further information is available at this time.This report will be updated should additional information become available.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator delivered anti-tachycardia pacing (atp) which accelerated the patient rhythm into a ventricular tachycardia.Data review revealed several episodes of atp and shocks delivered.This device was also noted to have exhibited oversensing of noise.This device remains in service.No 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: 10292220
• MDR Text Key: 199489939
• Report Number: 2124215-2020-14596
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/08/2019
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 165286
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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 Age: 66 YR