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

Model Number G173

Device Problems Unexpected Therapeutic Results (1631); Under-Sensing (1661)

Patient Problem Syncope (1610)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

Summary of the investigation: with the available information, bsc cannot confirm the clinical observations due to lack of product return.Device technical analysis: this device remains implanted and in service; therefore, a 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.Investigation conclusion: reported adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions).

Event Description

It was reported that the patient was presented to the emergency room due to syncope.The patient experienced ventricular tachycardia (vt) and was undersensed by the device.The patient lost consciousness approximately three to four minutes.The physician reprogrammed the device and this device remains in service.No additional 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
• 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: 10329557
• MDR Text Key: 200587721
• Report Number: 2124215-2020-15675
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/07/2019
• Device Model Number: G173
• Device Catalogue Number: G173
• Device Lot Number: 122649
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2017
• 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 Outcome(s): Hospitalization; Required Intervention