MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND INOGEN; IMPLANTABLE CHF GENERATOR

Model Number G148

Device Problems Device Alarm System (1012); High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.

Event Description

Boston scientific received information that the patient reported hearing tones from the cardiac resynchronization therapy defibrillator (crt-d).The patient was brought into the clinic where the noise was reproduced.The clinic noted there has been noise on the right atrial (ra) channel previously.Intermittent high out of range pacing impedance measurements of greater than 3000 ohms were also observed for the crt-d and another manufacturer's ra lead, which was the cause of the tones.Boston scientific technical services (ts) was consulted and reviewed the data stored in the remote home monitoring system.It was noted that there has been intermittent oversensing of noise along with intermittent fluctuating ra impedance measurements from 500 ohms to greater than 3000 ohms.Ts advised that the noise was due to the crt-d oversensing the minute ventilation signal and recommended programming the rate respond trend (rrt) feature off.The medical personnel stated the patient reported generally not feeling well.Ts further recommended evaluation of the lead and device to assess the reason for the high impedance measurements.The tones and the rrt features were programmed off and the patient was scheduled for a revision procedure in the future.The crt-d and another manufacturer's ra lead remain in service and no adverse patient effects were reported.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

Additional information was received that a revision procedure was performed where the crt-d and another manufacturer's ra lead were explanted and successfully replaced.No additional adverse patient effects were reported.

• Brand Name: INOGEN
• Type of Device: IMPLANTABLE CHF GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7615437
• MDR Text Key: 111661355
• Report Number: 2124215-2018-10247
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

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: 06/09/2017
• Device Model Number: G148
• Other Device ID Number: INOGEN X4 CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 07/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2015
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR