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

Model Number J176

Device Problems Electrical /Electronic Property Problem (1198); Reset Problem (3019)

Patient Problem Atrial Flutter (1730)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned. If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

Boston scientific received information that the patient implanted with this pacemaker was found to be in atrial flutter during a normal follow up clinic visit. The physician attempted to cardiovert the patient by using atrial burst pacing however a warning screen displayed on the programmer informing the physician that the device was now operating in safety mode. Boston scientific technical services (ts) recommended device replacement. No adverse patient effects were reported. The device was explanted and is expected to be returned for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed. A visual inspection of the device header and case noted no anomalies. The device was confirmed to be in safety mode. The device was programmed out of safety mode and back into operation mode. 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. Examination of the device memory confirmed that the device went into safety mode as a result of experiencing firmware resets. This family of devices has been specifically designed such that if three system resets occur within a 48-hour period, a device will enter safety mode.

• 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: 5599565
• MDR Text Key: 43439296
• Report Number: 2124215-2016-02756
• 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

• Type of Report: Initial,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/09/2015
• Device Model Number: J176
• Other Device ID Number: INGENIO MRI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/22/2016 Patient Sequence Number: 1