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

Model Number	G146
Medical Device Problem Codes	Premature Discharge of Battery (1057); High impedance (1291); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.This device had 2 years of battery life remaining.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Technical services (ts) consultant recommended replacement.This crt-d was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.This device had 2 years of battery life remaining.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Technical services (ts) consultant recommended replacement.This crt-d was explanted and replaced.No additional adverse patient effects were reported.Additional information was received that this cardiac resynchronization therapy defibrillator (crt-d) had recorded high out of range pacing impedances on the left ventricular (lv) channel prior to explanation.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.This device had 2 years of battery life remaining.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Technical services (ts) consultant recommended replacement.This crt-d was explanted and replaced.No additional adverse patient effects were reported.Additional information was received that this cardiac resynchronization therapy defibrillator (crt-d) had recorded high out of range pacing impedances on the left ventricular (lv) channel prior to explanation.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.External visual inspection of the device revealed no anomalies.Review of the device memory confirmed that a low voltage alert was recorded.The battery voltage level upon receipt in the laboratory was sufficient to ensure therapy availability/delivery while the device was implanted.The device case was then opened to facilitate analysis of the internal components.The battery was separated from the other device electronics and the overall current draw of the circuitry was measured.A normal current drain was observed within the circuitry.Detailed battery analysis determined that a latent current leakage path had occurred within the battery itself, resulting 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.

• Brand Name: INOGEN? X4 CRT-D
• Common Device Name: 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: 22731909
• Report Number: 2124215-2025-54877
• Device Sequence Number: 9051146
• Product Code: NIK
• UDI-Device Identifier: 00802526534577
• UDI-Public: (01)00802526534577(17)170402
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/02/2017
• Device Model Number: G146
• Device Catalogue Number: G146
• Device Lot Number: 370047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 07/10/2025; 12/17/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 08/07/2025; 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male