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

Model Number K187

Device Problems Ambient Noise Problem (2877); Connection Problem (2900)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 02/04/2014

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 the patient with this atrial lead presented to the hospital with shortness of breath.Device interrogation revealed noise.In addition, multiple atrial tachy response (atr) episodes with noise/artifact were stored.Real time maneuvers resulted in noise on the atrial channel only.Thresholds and sensing were good.Acceptable impedance measurements were obtained.An internal technical service (ts) consultant was contacted.The minute ventilation sensor was programmed off.Resulting electrogram revealed only intermittent noise; more consistent of a lead fracture as impedance measurements are not affected.An x-ray was performed revealing no fracture.A loop near the device was noted which was thought may have caused the issue.A copy of the x-ray and a memory download will be provided to ts for their review.Engineering reviewed the data.There was no clear indication that the lead has a fracture or a connection related issue.The fluoroscopy images were examined and were not able to discern any issues with the lead connections to the device which appeared fully inserted.Setscrews appear tightened appropriately, however it could not be determined whether there was a loose setscrew from the image.The images display a significant bend in the leads where the suture sleeves are located, however it was thought this was likely due to the aspect of the x-ray image and not caused by a bend or kink in the lead itself.It was recommended trying to duplicate the issue by touching the location of the suture sleeves to see if that area is causing the noise.A follow up visit was performed.The device was reprogrammed and a save to disc was provided to ts.After review, ts indicted the noise was likely due to intermittent lead fracture with no evidence to suggest a connection issue.No 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: 5373401
• MDR Text Key: 36537912
• Report Number: 2124215-2016-00480
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• 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: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/30/2015
• Device Model Number: K187
• Other Device ID Number: INGENIO MRI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2013
• 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 Age: 47 YR