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

Model Number G179

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Failure to Read Input Signal (1581)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

This device remains implanted, therefore technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.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

It was reported that this patient was hospitalized due to shortness of breath.Interrogation of the cardiac resynchronization therapy defibrillator (crt-d) device, exhibited over-sensed noise on the right ventricular (rv) channel.A technical service (ts) consultant reviewed the available device data and recommended programming to change the sensitivity settings from 0.6 mv to 1.5 mv.Ts advised some of the noise on the rv channel to be myopotentials related, and only appear when the patient is taking a deep breath.There was no pacing inhibition reported, and no out of range measurements reported.Ts recommended lead integrity testing.The device remains implanted.No adverse patient effects were reported.Additional information was received, programming changes were made to decrease the sensitivity to 1.0 mv.Deep breathing tested was completed, and no over sensing occurred.The patient was discharged home with a holter monitor and will follow up in approximately one month.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12112247
• MDR Text Key: 260424949
• Report Number: 2124215-2021-10503
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/25/2016
• Device Model Number: G179
• Device Catalogue Number: G179
• Device Lot Number: 104511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other