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

Model Number G179

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that the battery of this cardiac resynchronization therapy defibrillator (crt-d) appeared to be depleting prematurely, as the estimated remaining longevity decreased from 1.5 years remaining to 6 months remaining over the course of approximately four months.A request was made to have data from this device analyzed.Data analysis showed the battery consumption had been increasing at an unexpected rate, and a technical services (ts) consultant recommended device replacement or repeat data analysis within 90 days.At this time, there is no evidence to suggest that intervention has been performed.No adverse patient effects were reported.

Event Description

It was reported that the battery of this cardiac resynchronization therapy defibrillator (crt-d) appeared to be depleting prematurely, as the estimated remaining longevity decreased from 1.5 years remaining to 6 months remaining over the course of approximately four months.A request was made to have data from this device analyzed.Data analysis showed the battery consumption had been increasing at an unexpected rate, and a technical services (ts) consultant recommended device replacement or repeat data analysis within 90 days.At this time, there is no evidence to suggest that intervention has been performed.No adverse patient effects were reported.To date, no additional information has been received.Should additional follow-up information be provided in the future, an updated report will be issued.

Manufacturer Narrative

This device remains implanted; therefore, technical analysis cannot be conducted.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: 18810033
• MDR Text Key: 336995671
• Report Number: 2124215-2024-12313
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/19/2017
• Device Model Number: G179
• Device Catalogue Number: G179
• Device Lot Number: 131908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2015
• 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