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

Model Number G148

Device Problems Electrical /Electronic Property Problem (1198); Over-Sensing (1438); Ambient Noise Problem (2877); Impedance Problem (2950)

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

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) and right atrial (ra) lead exhibited noise and intermittent oversensing resulting in inappropriate atrial tachy response (atr) mode switches.Review of stored device memory noted fluctuating ra pacing impedance measurements with the highest measurement reaching 1,200 ohms.Boston scientific technical services (ts) reviewed the episodes and discussed that the noise was consistent with oversensing related to the minute ventilation (mv) feature and recommended programming the respiratory rate trend (rrt) off.Rrt was programmed off.No adverse patient effects were reported.This product remains implanted and in service.

• 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: 7614682
• MDR Text Key: 111514421
• Report Number: 2124215-2018-06376
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/04/2018

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: 03/10/2016
• Device Model Number: G148
• Other Device ID Number: INOGEN X4 CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2014
• 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: 0292; 4135; 4674; G148
• Patient Age: 65 YR