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

Model Number G141

Device Problems Electrical /Electronic Property Problem (1198); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 patient has been very sick with multiple valve surgeries, is blind and has cognitive disabilities.The patient presented to the emergency room one month ago with ventricular tachycardia (vt) which was not able to be terminated with the device.The patient was most recently in the hospital due to an infection.The patient's cardiac resynchronization therapy defibrillator (crt-d) was explanted.During treatment for the infection, the implantable cardioverter defibrillator (icd) that had been electively abandoned previously in this patient's abdomen, was programmed back on.The device was programmed to electro- cautery mode due to oversensing in voo mode and the patient was placed on a life vest.Difficulty establishing telemetry was reported and there were pauses in pacing despite the device being in electro-cautery mode.Threshold measurements were elevated and the device was programmed to higher outputs and the patient is paced 100 % in the right ventricle (rv).The caller was inquiring if the icd would last the full ninety days from elective replacement indicator (eri) which was set on (b)(6) 2015.A download of the device data confirmed the device is depleting normally and should suffice until the patient's infection is resolved.Following resolution of the infection, the icd and the associated leads were laser extracted and replaced.There was some vegetation noted on the rv lead.No other 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5409477
• MDR Text Key: 37422731
• Report Number: 2124215-2016-02184
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/03/2015

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: 03/05/2017
• Device Model Number: G141
• Other Device ID Number: INOGEN 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: 12/03/2015
• Initial Date FDA Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2015
• 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
• Treatment: 0085
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 290 MO