MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOGEN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G177

Device Problems Device Sensing Problem (2917); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2019

Event Type  Injury  

Manufacturer Narrative

The explanted device was received and is undergoing laboratory analysis.This report will be updated when analysis is complete.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and associated non-boston scientific right ventricular (rv) lead exhibited noise during inspiration/expiration on the rate/sense channel.However, this noise was not being sensed by the device.Additional troubleshooting was performed the following month, and the minute ventilation (mv) sensor was programmed off to see if this was the cause of the noise.The same noise remained, and noise was created with certain arm movements.Device data was submitted to technical services for review.No episodes were stored showing the noise, so additional testing was recommended to run egms during testing so the morphology of the noise could be evaluated by technical services.The pacing impedance trends of the lead did not show any suspicious values, indicating the lead conductor is likely not impaired.X-rays could be considered to evaluate the connection between the terminal pin and device header.In april the field representative reported that the competitor's rv lead was explanted and replaced with a non-boston scientific df-4 model and the current device was therefore replaced with a df-4 header device.The physician questioned whether the device header was the source of the noise so the explanted device was returned for laboratory analysis.No adverse patient effects were reported.

Manufacturer Narrative

The explanted device was received and is undergoing laboratory analysis.This report will be updated when analysis is complete.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 seal plugs were intact and the setscrews moved freely.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, 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.Analysis did not identify any device characteristics that would have caused or contributed to the reported noise on the rv channel.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and associated non-boston scientific right ventricular (rv) lead exhibited noise during inspiration/expiration on the rate/sense channel.However, this noise was not being sensed by the device.Additional troubleshooting was performed the following month, and the minute ventilation (mv) sensor was programmed off to see if this was the cause of the noise.The same noise remained, and noise was created with certain arm movements.Device data was submitted to technical services for review.No episodes were stored showing the noise, so additional testing was recommended to run egms during testing so the morphology of the noise could be evaluated by technical services.The pacing impedance trends of the lead did not show any suspicious values, indicating the lead conductor is likely not impaired.X-rays could be considered to evaluate the connection between the terminal pin and device header.In april the field representative reported that the competitor's rv lead was explanted and replaced with a non-boston scientific df-4 model and the current device was therefore replaced with a df-4 header device.The physician questioned whether the device header was the source of the noise so the explanted device was returned for laboratory analysis.No adverse patient effects were reported.

• Brand Name: AUTOGEN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8870220
• MDR Text Key: 153561086
• Report Number: 2124215-2019-16902
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

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: 04/05/2016
• Device Model Number: G177
• Device Catalogue Number: G177
• Device Lot Number: 102485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 10/28/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR