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

Model Number G146

Device Problem Delayed Charge Time (2586)

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

Event Date 07/01/2022

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had reached to elective replacement indicator (eri).Technical services (ts) was concerned that the most recent charge times were twenty four seconds.The patient receives plenty of therapy.Subsequently, this device was explanted and successfully replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

This device was thoroughly inspected and analyzed.External visual inspection identified no anomalies.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.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had reached to elective replacement indicator (eri).Technical services (ts) was concerned that the most recent charge times were twenty four seconds.The patient receives plenty of therapy.Subsequently, this device was explanted and succesfully replaced.No additional adverse patient effects were reported.

• Brand Name: INOGEN X4 CRT-D
• Type of Device: 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: 15048222
• MDR Text Key: 296123862
• Report Number: 2124215-2022-26229
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534577
• UDI-Public: 00802526534577
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/09/2016
• Device Model Number: G146
• Device Catalogue Number: G146
• Device Lot Number: 102522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2014
• 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): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male