MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND TELIGEN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number E110

Device Problems Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

The device is being evaluated in our post market quality assurance laboratory.This product issue will be updated when evaluation is complete.

Event Description

Boston scientific received information that this device was explanted due to the patient receiving a heart transplant.The device was programmed to electrocautery protection mode prior to surgery.A magnet was applied due to some issues during the procedure.A health care provider reported that device interrogation following the surgery revealed the device was no longer programmed to electrocautery protection mode.The caller inquired if magnet application could have caused the programming change.A boston scientific technical services consultant stated this would not occur as a result of magnet application and the programming must have been cancelled.A boston scientific sales representative was called to the facility and was informed that device interrogation was now unsuccessful despite the use of two programmers and three wands.Additionally, the device was hot to the touch.The representative confirmed interrogation was unsuccessful and stated the device was warm.The representative also noted that the device did not respond to magnet application.The device has been returned for testing.No adverse patient effects were reported.

Manufacturer Narrative

This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.It was confirmed the device could not be telemetered.A visual examination identified a small arc mark on the exterior of the device case (image).This mark is indicative of external energy directly applied to the device case.The device case was removed to facilitate inspection and testing of the internal components.A small witness mark on the inside of the device case corresponding to the arc mark on the exterior of the case was identified.The battery voltage was measured at 0 volts.The battery was removed and replaced with an external power source.Testing revealed a high current draw.Photon emission microscopy was performed which identified a damaged area of the mixed mode integrated circuit (mmic) as the source of the high current draw.Analysis concluded this device was damaged due to exposure to external energy strong enough to damage the exterior of the device case as well as the internal circuitry of the device.This likely induced a reset which is why the device was no longer operating in electrocautery protection mode.The damage to the mmic resulted in a high current draw that rapidly depleted the battery causing the observed warming of the device and inability to interrogate it.

• Brand Name: TELIGEN
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7615304
• MDR Text Key: 111673127
• Report Number: 2124215-2018-08852
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/29/2012
• Device Model Number: E110
• Other Device ID Number: TELIGEN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2011
• 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: 36 YR