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 03/08/2024

Event Type  malfunction  

Event Description

It was reported that this pacemaker was suspected of exhibiting premature battery depletion behavior.During a routine follow-up visit, the estimated battery longevity was showing only 1.5 years remaining with 500% power consumption.The physician requested that the device be re-interrogated to determine if there were any optimizations needed to assist with battery longevity.Another follow-up with the patient was scheduled a few days later after the previous follow-up visit.This time, the battery longevity was showing 1 year remaining and the power consumption increased to 536% usage.During this interrogation, all testing was completed, and the values all appeared within normal range.Device settings were evaluated with all settings seeming optimized.A copy of device memory was saved and submitted to technical services (ts) for further review.A ts consultant confirmed the suspected premature depletion and recommended immediate replacement.This device currently remains implanted and in service.No adverse patient effects were reported.

Event Description

It was reported that this pacemaker was suspected of exhibiting premature battery depletion behavior.During a routine follow-up visit, the estimated battery longevity was showing only 1.5 years remaining with 500% power consumption.The physician requested that the device be re-interrogated to determine if there were any optimizations needed to assist with battery longevity.Another follow-up with the patient was scheduled a few days later after the previous follow-up visit.This time, the battery longevity was showing 1 year remaining and the power consumption increased to 536% usage.During this interrogation, all testing was completed, and the values all appeared within normal range.Device settings were evaluated with all settings seeming optimized.A copy of device memory was saved and submitted to technical services (ts) for further review.A ts consultant confirmed the suspected premature depletion and recommended immediate replacement.This device currently remains implanted and in service.No adverse patient effects were reported.Additional information: new information was provided from the field representative indicating that this device was explanted and replaced.No additional adverse patient effects were reported.This device is expected for return.

Manufacturer Narrative

This device is expected for return.Following completion of laboratory analysis, this event will be further updated.

• 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: 18979985
• MDR Text Key: 338689697
• Report Number: 2124215-2024-18224
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G179
• Device Catalogue Number: G179
• Device Lot Number: 287646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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