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

Model Number G148

Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

At this time, the product remains in service.If additional information is received, this report will be updated.

Event Description

Boston scientific received information that inappropriate atrial tachy response (atr) episodes were stored on this cardiac resynchronization therapy defibrillator (crt-d).Review of the events indicated noise consistent with minute ventilation sensor oversensing, on the atrial channel of this crt-d.The atrial lead was another manufacturer's lead.There were a couple of spikes in atrial pace impedance up to 800 ohms, and an alert was also recently triggered for a high out of range atrial impedance.The longest period of oversensing that was noted, was 17 seconds; however this patient is not pacemaker dependent and is only paced 3% of the time.The patient is scheduled to have the respiratory rate trend feature programmed off.No 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: 7614959
• MDR Text Key: 111659893
• Report Number: 2124215-2018-08826
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/02/2018
• 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
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2016
• 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
• Patient Age: 41 YR