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

Model Number G148

Device Problem Pacing Problem (1439)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 06/28/2016

Event Type  Injury  

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 the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) was to undergo an mri.Testing was performed and it was deemed that the patient's intrinsic rhythm was acceptable to undergo the procedure.The crt-d was programmed to mri protection mode prior to mri exposure.Before the mri scan was conducted, the patient became asystolic and required cardiopulmonary resuscitation (cpr).The crt-d was reprogrammed out of mri protection mode and the patient recovered fully.The patient was reported to suffer from intermittent complete atrioventricular (av) block and was hospitalized.The patient was discharged at a later date and the crt-d remains in service.No additional adverse patient effects were reported.Although the crt-d is approved for sale in (b)(6), the software that includes the mri protection mode feature is under clinical trial investigation.This feature, when enabled, suspends bradycardia therapy during the mri scan.This is communicated in the device labeling.Based on the observations, it is likely that the event was due to a previously unrecognized intermittent third degree av block resulting in transient pacemaker dependency.It was confirmed that a future mri scan will not be performed due to these recent changes in the patient's condition.

• 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: 5795838
• MDR Text Key: 49619260
• Report Number: 2124215-2016-11425
• 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: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2016

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: 12/18/2016
• Device Model Number: G148
• Other Device ID Number: INOGEN X4 CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2014
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 70