MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN EL ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number D141

Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)

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

Event Date 04/04/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirmed low voltage fault.Moreover, it was determined that the device hardware was not detecting the loss of battery energy that the battery status indicators were not reflecting the depletion condition and were inaccurate.The device was malfunction and device replacement was recommended.To date, there was no intervention done and the device remains in service.Additional information from the field indicated that patient was scheduled for device change.No adverse patient effects were reported.

Event Description

It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirmed low voltage fault.Moreover, it was determined that the device hardware was not detecting the loss of battery energy that the battery status indicators were not reflecting the depletion condition and were inaccurate.The device was malfunction and device replacement was recommended.To date, there was no intervention done and the device remains in service.Additional information from the field indicated that patient was scheduled for device change.Additional information was provided that the device was explanted and returned.No additional adverse patient effects were reported.

Manufacturer Narrative

The product has been received for analysis.Upon completion of the analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirmed low voltage fault.Moreover, it was determined that the device hardware was not detecting the loss of battery energy that the battery status indicators were not reflecting the depletion condition and were inaccurate.The device was malfunction and device replacement was recommended.To date, there was no intervention done and the device remains in service.Additional information from the field indicated that patient was scheduled for device change.Also, the device was explanted and returned.No additional adverse patient effects were reported.

Manufacturer Narrative

The product has been received for analysis.Upon completion of the analysis of the complaint product, if there is any further relevant information from that review, a supplemental report will be filed.This device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Review of the device memory confirmed that a low voltage alert was recorded.Although the device memory diagnostics demonstrated that the daily battery voltage measurements displayed an irregular pattern of discharge, the battery voltage level upon receipt in the laboratory remained sufficient to ensure therapy availability/delivery while the device was implanted.Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a latent current leakage path within the battery itself, which resulted in a partial depletion of the battery.This behavior is caused by a latent electrical leakage path that develops over time between the anode and cathode within the device battery.In certain circumstances, lithium metal ions can re-plate to form clusters that may result in an internal current leakage.A design enhancement was implemented in 2013 to enlarge the physical barrier between the electrode layers to prevent current leakage in the area of the battery that is most often affected by this behavior.

• Brand Name: INOGEN EL ICD VR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 14497854
• MDR Text Key: 292732525
• Report Number: 2124215-2022-14605
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534225
• UDI-Public: 00802526534225
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/27/2017
• Device Model Number: D141
• Device Catalogue Number: D141
• Device Lot Number: 192637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2015
• 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
• Patient Age: 77 YR
• Patient Sex: Male