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

Model Number G173

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

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

Event Date 08/31/2023

Event Type  Injury  

Event Description

It was reported that this device was suspected of exhibiting premature battery depletion behavior.Technical services were consulted, and engineering analysis has confirmed a gradual increase in power consumption and indicates that there is a chance the device may trigger elective replacement indicator (eri) within 60 days.Due to this anomaly, device replacement was recommended.No adverse patient effects were reported.This device currently remains implanted and in service.

Manufacturer Narrative

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 device was suspected of exhibiting premature battery depletion behavior.Technical services were consulted, and engineering analysis has confirmed a gradual increase in power consumption and indicates that there is a chance the device may trigger elective replacement indicator (eri) within 60 days.Due to this anomaly, device replacement was recommended.No adverse patient effects were reported.This device currently remains implanted and in service.Additional information: despite numerous attempts to obtain additional details, no further correspondence was received from the field.Should additional information become available, a supplemental report will be provided.

Manufacturer Narrative

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 device was suspected of exhibiting premature battery depletion behavior.Technical services were consulted, and engineering analysis has confirmed a gradual increase in power consumption and indicates that there is a chance the device may trigger elective replacement indicator (eri) within 60 days.Due to this anomaly, device replacement was recommended.No adverse patient effects were reported.This device currently remains implanted and in service.Additional information: despite numerous attempts to obtain additional details, no further correspondence was received from the field.Should additional information become available, a supplemental report will be provided.*update/additional information*: new information was received via our device tracking system which indicates that this device was explanted and replaced on (b)(6) 2023.No additional adverse patient effects were reported.This device is not expected for return.Should the device be received, a product investigation will be completed, and a supplemental report will be provided.

• 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: 17712547
• MDR Text Key: 322982448
• Report Number: 2124215-2023-49042
• 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: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/29/2017
• Device Model Number: G173
• Device Catalogue Number: G173
• Device Lot Number: 112513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention