MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND INGENIO; IMPLANTABLE PULSE GENERATOR

Model Number J174

Device Problems Pacing Problem (1439); Device Operates Differently Than Expected (2913)

Patient Problem Atrial Flutter (1730)

Event Date 03/14/2016

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory a thorough product analysis was performed.Review of the device memory confirmed several atrial tachycardia response episodes.Three faults occurred within approximately five minutes of each other; therefore, the device automatically enters safety mode.The device was taken out of safety mode and the device reverted to primary operation.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.As a result, analysis confirmed the clinical observations.

Event Description

Boston scientific received information that the patient with this device had atrial flutter.When the physician attempted to stimulate faster than the atrial flutter, the overstimulation resulted in the device indicating safety mode.As a result, a device replacement was scheduled.This device was explanted and replaced.The two competitor leads were also removed from service.No additional adverse patient effects were reported.

• Brand Name: INGENIO
• Type of Device: IMPLANTABLE PULSE 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: 5603184
• MDR Text Key: 43500363
• Report Number: 2124215-2016-05703
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/12/2016
• Device Model Number: J174
• Other Device ID Number: INGENIO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2014
• 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
• Treatment: 4076
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention