MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G148

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Delayed Charge Time (2586); Battery Problem (2885)

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

Event Date 04/03/2022

Event Type  Injury  

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 device interrogation identified remaining remaining longevity had decreased from 1.5 years to elective replacement indicator (eri) in four months.Additionally, a message was noted stating there was a charge time greater than 25 seconds.A boston scientific engineer evaluated the battery status and identified the charge time had more than doubled since the last capacitor reform.The current charging data showed the charge current is lower.The engineer informed the caller that prompt replacement of the device is recommended.The device was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

This device was thoroughly inspected and analyzed.Review of device memory confirmed that the device had reached eri battery status due to long charge times.Testing confirmed that an internal component was not securely attached to the circuit substrate.This open connection was between a diode component within charging circuitry and the electronics substrate.This incomplete electrical pathway within the shock charging circuitry of the device resulted in the lengthened charge times that triggered eri (note that the battery was not depleted, but replacement indicators were triggered because capacitor charging was not accomplished within the specified time).Engineers determined that the conductive epoxy used to connect the diode component to the printed circuit board did not create a secure connection.Despite exhibiting extended charge times, the maximum shock energy was still available and therapy availability is not compromised in devices exhibiting this issue.Therapy would have been available to the patient (if required), albeit with a somewhat longer charge time.This intermittent connection manifests during capacitor reformations or therapy charges.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 device interrogation identified remaining remaining longevity had decreased from 1.5 years to elective replacement indicator (eri) in four months.Additionally, a message was noted stating there was a charge time greater than 25 seconds.A boston scientific engineer evaluated the battery status and identified the charge time had more than doubled since the last capacitor reform.The current charging data showed the charge current is lower.The engineer informed the caller that prompt replacement of the device is recommended.The device was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: INOGEN X4 CRT-D
• 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: 14529236
• MDR Text Key: 292969085
• Report Number: 2124215-2022-16183
• 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: 05/31/2023

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: 04/07/2016
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 103620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male