MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOGEN; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 10/24/2023

Event Type  Injury  

Event Description

It was reported that the battery of this implantable cardiac resynchronization therapy defibrillator (crt-d) device was suspected to be depleting prematurely.The remaining estimated longevity decreased from 2 years to the elective replacement indicator (eri) over the course of 2 days.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.This device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

At this time, no further information is available.Should relevant additional information become available this report will be updated.

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis, should further pertinent information be provided.At this time, no further information is available.Should relevant additional information become available this report will be updated.

Event Description

It was reported that the battery of this implantable cardiac resynchronization therapy defibrillator (crt-d) device was suspected to be depleting prematurely.The remaining estimated longevity decreased from 2 years to the elective replacement indicator (eri) over the course of 2 days.A request was made to have data from this device analyzed.Data analysis has not been completed at this time.This device remains in service.No adverse patient effects were reported.Additional information was received which indicated that the data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.The device was explanted and returned for analysis.No additional adverse patient effects were reported.

Event Description

It was reported that the battery of this implantable cardiac resynchronization therapy defibrillator (crt-d) device was suspected to be depleting prematurely.The remaining estimated longevity decreased from 2 years to the elective replacement indicator (eri) over the course of 2 days.A request was made to have data from this device analyzed.Data analysis has not been completed at this time.This device remains in service.No adverse patient effects were reported.Additional information was received which indicated that the data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.The device was explanted and returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

At this time, no further information is available.Should relevant additional information become available this report will be updated.

Event Description

It was reported that the battery of this implantable cardiac resynchronization therapy defibrillator (crt-d) device was suspected to be depleting prematurely.The remaining estimated longevity decreased from 2 years to the elective replacement indicator (eri) over the course of 2 days.A request was made to have data from this device analyzed.Data analysis has not been completed at this time.This device remains in service.No adverse patient effects were reported.Additional information was received which indicated that the data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.The device was explanted and returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

At this time, no further information is available.Should relevant additional information become available this report will be updated.

• Brand Name: AUTOGEN
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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: 18091191
• MDR Text Key: 327601212
• Report Number: 2124215-2023-62715
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2018
• Device Model Number: G179
• Device Catalogue Number: G179
• Device Lot Number: 161081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2016
• 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
• Patient Age: 80 YR
• Patient Sex: Male