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

Model Number G141

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

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

Event Date 04/01/2018

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) exhibited noise oversensing on the right atrial (ra) channel.The noise oversensing led to inappropriate mode switches and a few spikes in atrial pacing impedances were also observed.A request was made to have data from this device analyzed by boston scientific technical services (ts).Ts reviewed the data and noted that the noise appeared to be related to the respiratory rate trend.Reprogramming and troubleshooting considerations were provided.The physician has elected to continue monitoring the system and perform testing at the next routine follow-up.The ra lead is a competitor product.This crt-d remains in service.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: 7620335
• MDR Text Key: 111707637
• Report Number: 2124215-2018-10903
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/22/2018
• Device Model Number: G141
• Other Device ID Number: INOGEN 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: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• 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: 4076; 4548; G141