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

Model Number G148

Device Problems High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2018

Event Type  malfunction  

Manufacturer Narrative

The device remains in service at this time.If additional information is received, this report will be updated.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) exhibited right atrial (ra) noise, oversensing, and inappropriate atrial tachy response (atr) episodes from minute ventilation (mv) oversensing.Additionally, ra impedance measurements were elevated, but were less than 2000 ohms.The patient would continue to be monitored.No adverse patient effects were reported.The device remains in service.

Manufacturer Narrative

The device remains in service at this time.If additional information is received, this report will be updated.

Event Description

Additional information received reported that the patient had an x-ray which did not show any signs of a lead issue; however, there was a possibility that the device had rotated.The patient would continue to be monitored.No adverse patient effects were reported.The device remains in service.

Manufacturer Narrative

The device remains in service at this time.If additional information is received, this report will be updated.

Event Description

This report is being filed to update evaluation coding.

Manufacturer Narrative

The device remains in service at this time.If additional information is received, this report will be updated.

Event Description

Additional information received reported that the ra impedance measurements increased to greater than 2500 ohms, and threshold measurements had increased.Patient isometrics were performed, which did not elicit any noise on the lead.Troubleshooting and programming options were discussed.No adverse patient effects were reported.The device remains in service.

• 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: 7984540
• MDR Text Key: 124351509
• Report Number: 2124215-2018-18062
• Device Sequence Number: 1
• Product Code: NIK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/10/2018
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 146973
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2016
• 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
• Treatment: 0184; 0292; 4135; 4470; 4554; 4591; 4674; G141; G148; N119
• Patient Age: 68 YR