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

Model Number G148

Device Problems Failure to Capture (1081); High impedance (1291); Device Displays Incorrect Message (2591); High Capture Threshold (3266)

Patient Problem Fall (1848)

Event Date 11/23/2018

Event Type  malfunction  

Event Description

It was reported that upon interrogation this cardiac resynchronization therapy defibrillator (crt-d) displayed an error code 1005 indicative of an open circuit condition being detected.Upon further review, the right ventricular (rv) lead was found to have high out-of-range shock impedance of greater than 200 ohms and high out-of-range pacing impedance of greater than 3,000 ohms.Additionally, there was no capture at the maximum output.The patient had previously received shock therapy that was appropriate.However, the patient reported falling due to the shock therapy delivered.That patient was not pacemaker dependent.Boston scientific technical services (ts) advised potentially replacing the lead and evaluating the device at that time as well.However, the physician elected not to take any further action regarding the issue as the patient was to begin hospice care.This product remains in service.No adverse patient effects were reported.

• Brand Name: INOGEN X4 CRT-D
• Type of Device: 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 CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8250206
• MDR Text Key: 133194257
• Report Number: 2124215-2019-00067
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2019

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: 04/03/2017
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 132544
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2015
• 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 Age: 83 YR