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

Model Number G179

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2023

Event Type  malfunction  

Event Description

It was reported that the remote home monitoring communicator displayed a red blinking light indicating a potential product performance anomaly with this cardiac resynchronization therapy defibrillator (crt-d).Technical services (ts) assisted the patient with troubleshooting to transmit data from the communicator to the server for review, however, troubleshooting was unsuccessful, and the patient was referred to their physician/clinic for further assistance.No adverse patient effects were reported.This device remains in service.Additional information has been requested.If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that the remote home monitoring communicator displayed a red blinking light indicating a potential product performance anomaly with this cardiac resynchronization therapy defibrillator (crt-d).Technical services (ts) assisted the patient with troubleshooting to transmit data from the communicator to the server for review, however, troubleshooting was unsuccessful, and the patient was referred to their physician/clinic for further assistance.No adverse patient effects were reported.This device remains in service.Additional information has been requested.If pertinent information is provided in the future, a supplemental report will be submitted.It was reported that the device was interrogated in clinic with a programmer.No remote home monitoring alert conditions or anomalies were noted during interrogation and monitoring will be continued.No adverse patient effects were reported.This device remains in service.If pertinent information is provided in the future, a supplemental report will be submitted.

• 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: 17901488
• MDR Text Key: 325287634
• Report Number: 2124215-2023-55793
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/09/2021
• Device Model Number: G179
• Device Catalogue Number: G179
• Device Lot Number: 213808
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• 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: 57 YR
• Patient Sex: Male