MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number G148

Device Problems Premature Discharge of Battery (1057); Defective Device (2588); Noise, Audible (3273)

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

Event Date 10/25/2021

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was exhibiting beeping.In addition, the patient reported device heating, which technical service described as atypical behavior.During medical consult, it was determined that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed the battery appeared to be depleting more quickly than expected, and a boston scientific technical services (ts) consultant recommended device replacement.This crt-d was explanted and successfully replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

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.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was exhibiting beeping.In addition, the patient reported device heating, which technical service described as atypical behavior.During medical consult, it was determined that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed the battery appeared to be depleting more quickly than expected, and a boston scientific technical services (ts) consultant recommended device replacement.This crt-d was explanted and successfully replaced.No additional adverse patient effects were reported.

• Brand Name: INOGEN X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 13137951
• MDR Text Key: 283180818
• Report Number: 2124215-2021-36515
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/07/2018
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 143913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 01/01/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male